The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Townley Pedicle Screw Plating System.
| Device ID | K970599 |
| 510k Number | K970599 |
| Device Name: | TOWNLEY PEDICLE SCREW PLATING SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Richard W Treharne, Ph.d. |
| Correspondent | Richard W Treharne, Ph.d. DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| 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 | 1997-02-18 |
| Decision Date | 1998-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902877148 | K970599 | 000 |
| 00721902659799 | K970599 | 000 |