Data / Medical devices / France / Safe Orthopaedics SAS
Safe Orthopaedics SAS: FDA-registered device maker in Fleurieux-Sur-L'Arbresle Rhone, France, 8 510(k) clearances
Safe Orthopaedics SAS is registered with the FDA (registration 3009509485) in Fleurieux-Sur-L'Arbresle Rhone, France. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 10, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009509485
- Address
- Zone Dactivite De Montepy 80 Rue De Montepy, Fleurieux-Sur-L'Arbresle Rhone, France, 69210
- Owner or operator
- Safe Orthopaedics (10039164)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 14, 2011
- Registered through
- 2027
- Brand names listed
- KIT OF CURVED LUMBAR CAGE, MEDINAUT Plus, RACKING COMPRESSION PLIER KIT, ROD BENDER FOR 5.5MM ROD, ROD INTRODUCER KIT, STERISPINE LC Lumbar Interbody Device, SYNTH Plus, SteriSpine Pedicle screw system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Exporter to the US | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Exporter to the US | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Exporter to the US | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2022 | K212358 | Romero Cervical Cage | OVE | Substantially Equivalent | Spineup, Inc. | accessdata.fda.gov |
| April 6, 2019 | K182287 | MEDINAUT Plus | HRX | Substantially Equivalent | Imedicom Co., Ltd. | accessdata.fda.gov |
| December 29, 2016 | K162531 | STERISPINE CC | OVE | Substantially Equivalent | Safe Orthopaedics | accessdata.fda.gov |
| March 14, 2014 | K133893 | STERISPINE LC CAGE | MAX | Substantially Equivalent | Safe Orthopaedics | accessdata.fda.gov |
| May 3, 2013 | K130632 | STERISPINE PS PEDICLE SCREW | NKB | Substantially Equivalent | Safe Orthopaedics | accessdata.fda.gov |
| September 20, 2012 | K122021 | STERISPINE LC CAGE | MAX | Substantially Equivalent | Safe Orthopaedics | accessdata.fda.gov |
| July 30, 2012 | K121299 | STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD | NKB | Substantially Equivalent | Safe Orthopaedics | accessdata.fda.gov |
| November 15, 2011 | K112453 | STERISPINEPS PEDICLE SCREW | NKB | Substantially Equivalent | Safe Orthopaedics | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Appliance, Fixation, Spinal Interlaminal
Updated January 10, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.