K093405 is an FDA 510(k) clearance for the PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES. This device is classified as a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II - Special Controls, product code MBH).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on May 25, 2010, 204 days after receiving the submission on November 2, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3565.
| 510(k) Number | K093405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2009 |
| Decision Date | May 25, 2010 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3565 |