The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.) Universal Sacral System.
| Device ID | K963045 |
| 510k Number | K963045 |
| Device Name: | SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Diane T Brown |
| Correspondent | Diane T Brown SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1997-02-13 |
| Summary: | summary |