The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Modification Of Townley Pedicle Screw Plating System.
| Device ID | K982154 |
| 510k Number | K982154 |
| Device Name: | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-19 |
| Decision Date | 1998-07-13 |
| Summary: | summary |