The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Modification To Townley Transfacetpedicular Screw Fixation System.
| Device ID | K013829 |
| 510k Number | K013829 |
| Device Name: | MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Rick W Treharne |
| Correspondent | Rick 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 | 2001-11-19 |
| Decision Date | 2001-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902319815 | K013829 | 000 |
| 00721902319518 | K013829 | 000 |
| 00721902319532 | K013829 | 000 |
| 00721902319617 | K013829 | 000 |
| 00721902319655 | K013829 | 000 |
| 00721902319679 | K013829 | 000 |
| 00721902319686 | K013829 | 000 |
| 00721902319693 | K013829 | 000 |
| 00721902319709 | K013829 | 000 |
| 00721902319730 | K013829 | 000 |
| 00721902319747 | K013829 | 000 |
| 00721902319778 | K013829 | 000 |
| 00721902319785 | K013829 | 000 |
| 00721902319792 | K013829 | 000 |
| 00721902319495 | K013829 | 000 |