Medicrea International
RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FR
MEDICREA INTERNATIONAL appears in FDA device records in RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FR. FDA records list 43 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 22 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Medicrea International between 2011 and 2022. The busiest year on record is 2016, with 8. The most recent is 2022, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 5 |
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 8 |
| 2017 | 4 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213659 | LigaPASS™ 2.0 Ligament Augmentation System | OWI | Substantially Equivalent | |
| K220810 | Infinity™ OCT System and PASS OCT Spinal System | NKG | Substantially Equivalent | |
| K220724 | CD Horizon™ Spinal System and PASS LP™ Spinal System | NKB | Substantially Equivalent | |
| K212005 | UNiD Spine Analyzer | LLZ | Substantially Equivalent | |
| K213281 | PASS LP™ Spinal System, CD Horizon™ Spinal System | NKB | Substantially Equivalent | |
| K210470 | C-CURVE Interbody Fusion Device | OVE | Substantially Equivalent | |
| K200316 | UNiD IB3D ALIF | MAX | Substantially Equivalent | |
| K191134 | IB3D ALIF | MAX | Substantially Equivalent | |
| K182158 | UNiD Patient-matched PLIF cage | MAX | Substantially Equivalent | |
| K190092 | UNiD Patient specific 3D printed TLIF cage | MAX | Substantially Equivalent | |
| K190376 | PASS LP Spinal System | NKB | Substantially Equivalent | |
| K182240 | PASS LP Spinal System | NKB | Substantially Equivalent | |
| K173782 | UNiD Patient Specific 3D printed cage | MAX | Substantially Equivalent | |
| K173506 | LigaPASS | OWI | Substantially Equivalent | |
| K180091 | UNiD Spine Analyzer | LLZ | Substantially Equivalent | |
| K163595 | IMPIX 3D Print Cages | MAX | Substantially Equivalent | |
| K172021 | LigaPASS | OWI | Substantially Equivalent | |
| K170172 | UNiD Spine Analyzer | LLZ | Substantially Equivalent | |
| K162786 | PASS LP Spinal System | NKB | Substantially Equivalent | |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System | KWQ | Substantially Equivalent | |
| K160640 | PASS XS Spinal System | NKB | Substantially Equivalent | |
| K160698 | LigaPASS | OWI | Substantially Equivalent | |
| K161627 | PASS LP Spinal System | NKB | Substantially Equivalent | |
| K161149 | PASS OCT Spinal System | NKG | Substantially Equivalent | |
| K160756 | PASS OCT Spinal System | NKG | Substantially Equivalent | |
| K153413 | PASS LP Spinal System | NKB | Substantially Equivalent | |
| K153169 | PASS OCT Patient Specific Rods | NKG | Substantially Equivalent | |
| K150918 | PASS OCT Spinal System | NKG | Substantially Equivalent | |
| K142798 | PASS LP Spinal System | MNH | Substantially Equivalent | |
| K150049 | PASS LP Spinal System | MNI | Substantially Equivalent | |
| K141187 | IMPIX ALIF S/A | OVD | Substantially Equivalent | |
| K141398 | PASS LP SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K140738 | PASS LP SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K133906 | C-JAWS CERVICAL COMPRESSIVE STAPLE | PHQ | Substantially Equivalent | |
| K132395 | LIGAPASS | OWI | Substantially Equivalent | |
| K132574 | PASS LP SPINAL SYSTEM | OSH | Substantially Equivalent | |
| K132575 | PASS LP SPINAL SYSTEM | OSH | Substantially Equivalent | |
| K121979 | PASS OCT SPINAL SYSTEM | KWP | Substantially Equivalent | |
| K123138 | PASS LP SPINAL SYSTEM | OSH | Unknown | |
| K121323 | MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE | KWQ | Substantially Equivalent | |
| K112736 | PASS LP SPINAL | JDQ | Substantially Equivalent | |
| K112493 | PASS LP SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K110497 | PASS LP SPINAL SYSTEM | MNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000432246 | 1000432246 | MEDICREA INTERNATIONAL | 5389 route de Strasbourg - Vancia, RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes 69140 FR | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PHQAnterior Staple As Supplemental Fixation For Fusion
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- QIHAutomated Radiological Image Processing Software
- HXWBender
- HTWBit, Drill
- OWIBone Fixation Cerclage, Sublaminar
- JDQCerclage, Fixation
- HWBExtractor
- HTJGauge, Depth
- HWAImpactor
- HTZInstrument, Cutting, Orthopedic
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- HXBProbe
- HTOReamer
- HXXScrewdriver
- HXRSpatula, Orthopedic
- LLZSystem, Image Processing, Radiological
- JACSystem, X-Ray, Film Marking, Radiographic
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1039-2026 | Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. | Class II | Open, Classified | |
| Z-1038-2026 | Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. | Class II | Open, Classified | |
| Z-1118-2025 | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. | Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification. | Class II | Open, Classified | |
| Z-2462-2023 | IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2461-2023 | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2460-2023 | IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2459-2023 | GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e) A13131789, f) A13132012, g) B13111014, h) B13111015, i) B13111016, j) B13111017, k) B13111025, l) B13111026, m) B13111027, n) B13111034, o) B13111035, p) B13111036; intervertebral fusion device - cervical | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2458-2023 | PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2457-2023 | IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2456-2023 | IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2455-2023 | IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2454-2023 | IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2453-2023 | IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-2452-2023 | IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | Class II | Open, Classified | |
| Z-0463-2021 | MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200 | Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention , | Class II | Terminated | |
| Z-1473-2020 | Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices. | An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step. | Class II | Terminated | |
| Z-1472-2020 | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices. | An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step. | Class II | Terminated | |
| Z-1234-2020 | Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500 | Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220) | Class II | Terminated | |
| Z-1156-2020 | Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010 | Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter | Class II | Terminated | |
| Z-0828-2020 | Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140 | Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded | Class II | Open, Classified | |
| Z-0827-2020 | Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130 | Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded | Class II | Open, Classified | |
| Z-0753-2020 | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, WIELOOSIOWA SRUBA TRANSPEDIKULARNA 7.5MM x 45MM, (01)03613720177906(10)19A0630(17)290103, RX only | It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Medicrea International edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain