The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Universal Spinal Hook, Rod, Pedicle/sacral Screw Fixation System.
| Device ID | K980928 |
| 510k Number | K980928 |
| Device Name: | SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-11 |
| Decision Date | 1998-05-11 |
| Summary: | summary |