K083107 is an FDA 510(k) clearance for the MODIFICATION TO DEPUY NEUFLEX PIP FINGER. This device is classified as a Prosthesis, Finger, Constrained, Polymer (Class II - Special Controls, product code KYJ).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 9, 2009, 112 days after receiving the submission on October 20, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3230.
| 510(k) Number | K083107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2008 |
| Decision Date | February 09, 2009 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KYJ - Prosthesis, Finger, Constrained, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3230 |