The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine Ps.
| Device ID | K151921 |
| 510k Number | K151921 |
| 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 Allee R. Luxembourg - Le 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 | 2015-07-13 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760219919582 | K151921 | 000 |
| 03760219912934 | K151921 | 000 |
| 03760219912910 | K151921 | 000 |
| 03760219912897 | K151921 | 000 |
| 03760219912873 | K151921 | 000 |
| 03760219912859 | K151921 | 000 |
| 03760219912835 | K151921 | 000 |
| 03760219912811 | K151921 | 000 |
| 03760219912798 | K151921 | 000 |
| 03760219912774 | K151921 | 000 |
| 03760219912750 | K151921 | 000 |
| 03760219912958 | K151921 | 000 |
| 03760219912972 | K151921 | 000 |
| 03760219919575 | K151921 | 000 |
| 03760219919568 | K151921 | 000 |
| 03760219919551 | K151921 | 000 |
| 03760219919544 | K151921 | 000 |
| 03760219913818 | K151921 | 000 |
| 03760219913757 | K151921 | 000 |
| 03760219913696 | K151921 | 000 |
| 03760219913689 | K151921 | 000 |
| 03760219913016 | K151921 | 000 |
| 03760219912996 | K151921 | 000 |
| 03760219912736 | K151921 | 000 |