The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Posterior Universal Spinal System.
| Device ID | K982987 |
| 510k Number | K982987 |
| Device Name: | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Contact | Jonathan M Gilbert |
| Correspondent | Jonathan M Gilbert SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-26 |
| Decision Date | 1998-10-21 |
| Summary: | summary |