The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Townley Transfacepedicular Screw Fixation System.
| Device ID | K021705 |
| 510k Number | K021705 |
| Device Name: | MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-23 |
| Decision Date | 2002-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994799623 | K021705 | 000 |
| 00613994723215 | K021705 | 000 |
| 00613994723222 | K021705 | 000 |
| 00613994723239 | K021705 | 000 |
| 00613994723246 | K021705 | 000 |
| 00613994723253 | K021705 | 000 |
| 00613994723260 | K021705 | 000 |
| 00613994723277 | K021705 | 000 |
| 00613994799555 | K021705 | 000 |
| 00613994799562 | K021705 | 000 |
| 00613994799579 | K021705 | 000 |
| 00613994799586 | K021705 | 000 |
| 00613994799593 | K021705 | 000 |
| 00613994799609 | K021705 | 000 |
| 00613994799616 | K021705 | 000 |
| 00613994723208 | K021705 | 000 |