Spineart SA
Plan-les-Ouates, CH
SPINEART SA appears in FDA device records in Plan-les-Ouates, CH. FDA records list 57 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Spineart SA between 2008 and 2026. The busiest year on record is 2014, with 8. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 8 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262639 | BAGUERA® C Cervical Disc Surgical Instruments | QLQ | Substantially Equivalent | |
| K261205 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | Substantially Equivalent | |
| K254158 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K242933 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K242890 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K242589 | Scarlet® AL-T | MAX | Substantially Equivalent | |
| K241644 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | OVD | Substantially Equivalent | |
| K240699 | SCARLET® AC-Ti | OVE | Substantially Equivalent | |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | Substantially Equivalent | |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | PML | Substantially Equivalent | |
| K230583 | Tryptik Ti | ODP | Substantially Equivalent | |
| K213470 | PERLA® TL Posterior Osteosynthesis System | NKB | Substantially Equivalent | |
| K210472 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K203506 | PERLA® TL posterior osteosynthesis system | NKB | Substantially Equivalent | |
| K203222 | PERLA TL Posterior Osteosynthesis System | NKB | Substantially Equivalent | |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | NKG | Substantially Equivalent | |
| K200312 | Tryptik Ti | ODP | Substantially Equivalent | |
| K193396 | PERLA® TL posterior osteosynthesis system | NKB | Substantially Equivalent | |
| K192993 | SCARLET AL-T | OVD | Substantially Equivalent | |
| K183630 | SPINEART Navigation Instrument System | OLO | Substantially Equivalent | |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | OVD | Substantially Equivalent | |
| K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | ODP | Substantially Equivalent | |
| K190071 | Perla® Posterior Cervico-Thoracic Fixation System | NKG | Substantially Equivalent | |
| K181818 | Scarlet AL-T | OVD | Substantially Equivalent | |
| K181203 | Juliet Ti | MAX | Substantially Equivalent | |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K173702 | Juliet Ti LL | MAX | Substantially Equivalent | |
| K172065 | SCARLET AC-T | ODP | Substantially Equivalent | |
| K172101 | ROMEO® 2 Posterior Osteosynthesis System | NKB | Substantially Equivalent | |
| K161888 | JULIET® LL Lateral Lumbar Cage | MAX | Substantially Equivalent | |
| K153621 | Juliet® Ti | MAX | Substantially Equivalent | |
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K153386 | Perla Posterior Cervico-Thoracic Fixation system | NKG | Substantially Equivalent | |
| K151104 | OTELO LL | GAD | Substantially Equivalent | |
| K151695 | Romeo posterior osteosynthesis system | MNH | Substantially Equivalent | |
| K143214 | SCARLET® AC-T Secured Anterior Cervical Cage | OVE | Substantially Equivalent | |
| K141135 | JULIET LL | MAX | Substantially Equivalent | |
| K142277 | JULIET PO | MAX | Substantially Equivalent | |
| K141314 | SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION | OVE | Substantially Equivalent | |
| K141835 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS | MNI | Substantially Equivalent | |
| K141508 | ROMEO 2 PAD POSTERIOR AXIAL DEVICE | PEK | Substantially Equivalent | |
| K140948 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNH | Substantially Equivalent | |
| K140474 | JULIET OL | MAX | Substantially Equivalent | |
| K133557 | JULIET LL LATERAL LUMBAR CAGE | MAX | Substantially Equivalent | |
| K130267 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNH | Substantially Equivalent | |
| K122366 | TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE | ODP | Substantially Equivalent | |
| K112108 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNI | Substantially Equivalent | |
| K111127 | ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007728266 | 3007728266 | SPINEART SA | Chemin du Pre-Fleuri 3, Plan-les-Ouates 1228 CH | 2026 | and 39 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
- HXWBender
- HTWBit, Drill
- PMLBone Cement, Posterior Screw Augmentation
- HXQCrimper, Pin
- FZSCurette, Surgical, General Use
- KIHDispenser, Cement
- GDIDissector, Surgical, General & Plastic Surgery
- HWRDriver, Prosthesis
- GEGElevator, Surgical, General & Plastic Surgery
- HWBExtractor
- GENForceps, General & Plastic Surgery
- HXEFork
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- HWAImpactor
- HWNInstrument, Compression
- MDMInstrument, Manual, Surgical, General Use
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- 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
- QLQManual Instruments Designed For Use With Total Disc Replacement Devices
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- HXBProbe
- MJOProsthesis, Intervertebral Disc
- HTRRasp
- LWKRazor, Surgical
- HTOReamer
- GADRetractor
- HTXRongeur
- HXXScrewdriver
- PEKSpinous Process Plate
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2280-2025 | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | Open, Classified | |
| Z-2279-2025 | Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No | Cannulated fenestrated polyaxial screws may be incorrectly labeled | Class II | Open, Classified | |
| Z-1758-2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis). | Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew | Class II | Open, Classified | |
| Z-1426-2023 | JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-S | JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay. | Class II | Open, Classified | |
| Z-1975-2021 | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm | Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size. | Class II | Terminated | |
| Z-0546-2020 | Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures | Inner blister pack label is incorrect and does not match the correct external box label. | Class III | Terminated | |
| Z-0342-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated | |
| Z-0341-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated | |
| Z-0340-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated | |
| Z-0339-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated | |
| Z-0338-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated | |
| Z-0337-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated | |
| Z-0336-2018 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions. | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain