K082231 is an FDA 510(k) clearance for the ASCENSION SILICONE PIP. This device is classified as a Prosthesis, Finger, Constrained, Polymer (Class II - Special Controls, product code KYJ).
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 12, 2009, 158 days after receiving the submission on August 7, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3230.
| 510(k) Number | K082231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2008 |
| Decision Date | January 12, 2009 |
| Days to Decision | 158 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 |