The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Townley Facet/pedicular Screw Plating System.
| Device ID | K953076 |
| 510k Number | K953076 |
| Device Name: | TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-30 |
| Decision Date | 1997-02-28 |
| Summary: | summary |