K131283 is an FDA 510(k) clearance for the PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES. This device is classified as a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II - Special Controls, product code HSN).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 5, 2013, 60 days after receiving the submission on May 6, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110.
| 510(k) Number | K131283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2013 |
| Decision Date | July 05, 2013 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |