The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.) Universal Spinal Hook, Rod And Pedicle/sacral Screw Fixation System.
| Device ID | K951626 |
| 510k Number | K951626 |
| Device Name: | SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane T Brown |
| Correspondent | Diane T Brown SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-07 |
| Decision Date | 1995-08-21 |