The following data is part of a premarket notification filed by Safe Orthopaedics with the FDA for Sterispine Ps Pedicle Screw.
| Device ID | K130632 |
| 510k Number | K130632 |
| Device Name: | STERISPINE PS PEDICLE SCREW |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SAFE ORTHOPAEDICS PARC DES BELLEVUES ALLEE R. LUXEMBOURG - LE 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-05-03 |
| Summary: | summary |