K032097 is an FDA 510(k) clearance for the DEPUY ACE VERSANAIL TIBIAL NAIL. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 8, 2003, 31 days after receiving the submission on July 8, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K032097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2003 |
| Decision Date | August 08, 2003 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB - Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |