The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine Ps Pedicle Screw.
| Device ID | K150092 |
| 510k Number | K150092 |
| Device Name: | STERISPINE PS Pedicle Screw |
| 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 Allee R.Luxembourg-Bat. Californie Eragny Sur Oise, FR 95610 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-16 |
| Decision Date | 2015-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760219913023 | K150092 | 000 |