K003928 is an FDA 510(k) clearance for the TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.
Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on January 17, 2001, 28 days after receiving the submission on December 20, 2000.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K003928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2000 |
| Decision Date | January 17, 2001 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |