Clariance-SAS
BEAURAINS Hauts-de-France, FR
CLARIANCE-SAS appears in FDA device records in BEAURAINS Hauts-de-France, FR. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Clariance-SAS between 2016 and 2021. The busiest year on record is 2017, with 3. The most recent is 2021, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 3 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202032 | Idys LLIF 3DTi | OVD | Substantially Equivalent | |
| K202956 | Erisma LP Navigated Instruments | OLO | Substantially Equivalent | |
| K200920 | Idys ALIF ZP 3DTi | MAX | Substantially Equivalent | |
| K192168 | Idys ALIF ZP 3DTi | OVD | Substantially Equivalent | |
| K191263 | Idys ALIF TiVac | OVD | Substantially Equivalent | |
| K183259 | Idys™ TLIF TiVac | MAX | Substantially Equivalent | |
| K172465 | Idys™ TLIF 3DTi Cages | MAX | Substantially Equivalent | |
| K172083 | Idys™ ALIF System | OVD | Substantially Equivalent | |
| K170163 | Erisma® LP Spinal Fixation System | NKB | Substantially Equivalent | |
| K162367 | Erisma® LP MIS | NKB | Substantially Equivalent | |
| K153326 | Erisma-LP Spinal Fixation System | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008992889 | 3008992889 | CLARIANCE-SAS | 18, rue Robespierre, BEAURAINS Hauts-de-France 62217 FR | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- FZOChisel, Surgical, Manual
- HTFCurette
- HWRDriver, Prosthesis
- HTEElevator
- HTDForceps
- HTJGauge, Depth
- HBXInstrument, Cranioplasty Material Forming
- 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
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HTRRasp
- GADRetractor
- HTXRongeur
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1821-2026 | Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative. | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain