Submission Details
| 510(k) Number | K051740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2005 |
| Decision Date | September 06, 2005 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |