Sterispine™ PS
Thoracolumbosacral Pedicle Screw System
Safe Orthopaedics
The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine™ Ps.
Pre-market Notification Details
| Device ID | K201648 |
| 510k Number | K201648 |
| Device Name: | Sterispine™ PS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Safe Orthopaedics Parc Des Bellevues, Allee R. Luxembourg-Bat. Californie Eragny Sur Oise, FR 95610 |
| Contact | Pierre Dumouchel |
| Correspondent | Pierre Dumouchel Safe Orthopaedics Parc Des Bellevues, Le Californie - Allee Rosa Luxemburg Eragny Sur Oise, FR 95610 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-18 |
| Decision Date | 2020-07-30 |
Trademark Results [Sterispine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERISPINE 90720535 not registered Live/Pending |
SAFE ORTHOPAEDICS 2021-05-19 |
 STERISPINE 85356563 4196928 Dead/Cancelled |
SAFE ORTHOPAEDICS 2011-06-27 |
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