The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispineps Pedicle Screw, Sterispineps Rod.
| Device ID | K121299 |
| 510k Number | K121299 |
| Device Name: | STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760219913870 | K121299 | 000 |
| 03760219913030 | K121299 | 000 |
| 03760219913184 | K121299 | 000 |
| 03760219916697 | K121299 | 000 |
| 03760219919643 | K121299 | 000 |
| 03760219919650 | K121299 | 000 |
| 03760219919667 | K121299 | 000 |
| 03760219919674 | K121299 | 000 |
| 03760219919681 | K121299 | 000 |
| 03760219911623 | K121299 | 000 |
| 03760219911562 | K121299 | 000 |
| 03760219910459 | K121299 | 000 |
| 03760219910473 | K121299 | 000 |
| 03760219910503 | K121299 | 000 |
| 03760219910572 | K121299 | 000 |
| 03760219910978 | K121299 | 000 |
| 03760219911159 | K121299 | 000 |
| 03760219911173 | K121299 | 000 |
| 03760219911449 | K121299 | 000 |
| 03760219919698 | K121299 | 000 |
| 03760219919704 | K121299 | 000 |
| 03760219910497 | K121299 | 000 |
| 03760219911470 | K121299 | 000 |
| 03760219911494 | K121299 | 000 |
| 03760219911531 | K121299 | 000 |
| 03760219911555 | K121299 | 000 |
| 03760219911579 | K121299 | 000 |
| 03760219911739 | K121299 | 000 |
| 03760219911753 | K121299 | 000 |
| 03760219911777 | K121299 | 000 |
| 03760219911456 | K121299 | 000 |
| 03760219911432 | K121299 | 000 |
| 03760219910961 | K121299 | 000 |
| 03760219910992 | K121299 | 000 |
| 03760219911012 | K121299 | 000 |
| 03760219911036 | K121299 | 000 |
| 03760219911050 | K121299 | 000 |
| 03760219911074 | K121299 | 000 |
| 03760219911098 | K121299 | 000 |
| 03760219911111 | K121299 | 000 |
| 03760219911791 | K121299 | 000 |