The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Townley Transfacetpedicular Screw Fixation System.
| Device ID | K003928 |
| 510k Number | K003928 |
| Device Name: | TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W 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 | 2000-12-20 |
| Decision Date | 2001-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994264237 | K003928 | 000 |
| 00673978067858 | K003928 | 000 |
| 00673978067841 | K003928 | 000 |
| 00673978067834 | K003928 | 000 |
| 00673978067827 | K003928 | 000 |
| 00673978067810 | K003928 | 000 |
| 00673978067803 | K003928 | 000 |
| 00673978067797 | K003928 | 000 |
| 00721902613371 | K003928 | 000 |
| 00721902298493 | K003928 | 000 |
| 00721902298479 | K003928 | 000 |
| 00721902298462 | K003928 | 000 |
| 00721902298455 | K003928 | 000 |
| 00721902298448 | K003928 | 000 |
| 00721902298431 | K003928 | 000 |
| 00721902043819 | K003928 | 000 |
| 00721902043802 | K003928 | 000 |
| 00673978067865 | K003928 | 000 |
| 00673978067872 | K003928 | 000 |
| 00681490860574 | K003928 | 000 |
| 00681490860567 | K003928 | 000 |
| 00681490860550 | K003928 | 000 |
| 00681490860543 | K003928 | 000 |
| 00681490860536 | K003928 | 000 |
| 00681490833240 | K003928 | 000 |
| 00673978067971 | K003928 | 000 |
| 00673978067964 | K003928 | 000 |
| 00673978067957 | K003928 | 000 |
| 00673978067940 | K003928 | 000 |
| 00673978067933 | K003928 | 000 |
| 00673978067926 | K003928 | 000 |
| 00673978067919 | K003928 | 000 |
| 00673978067902 | K003928 | 000 |
| 00673978067896 | K003928 | 000 |
| 00673978067889 | K003928 | 000 |
| 00721902043796 | K003928 | 000 |