K102549 is an FDA 510(k) clearance for the THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY. This device is classified as a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained.
Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on December 21, 2010, 105 days after receiving the submission on September 7, 2010.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K102549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2010 |
| Decision Date | December 21, 2010 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZJ — Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Device Class | — |