K021705 is an FDA 510(k) clearance for the MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR 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 July 24, 2002, 62 days after receiving the submission on May 23, 2002.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K021705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2002 |
| Decision Date | July 24, 2002 |
| Days to Decision | 62 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MRW — System, Facet Screw Spinal Device |
| Device Class | — |