The following data is part of a premarket notification filed by Synthes Spine with the FDA for Universal Spinal Rod And Screw Fixation System.
| Device ID | K943725 |
| 510k Number | K943725 |
| Device Name: | UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Contact | Diane Brown |
| Correspondent | Diane Brown SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-01 |
| Decision Date | 1995-08-25 |