K151615 is an FDA 510(k) clearance for the TiTHON Staple with OsseoTi Technology. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 2, 2015, 109 days after receiving the submission on June 15, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K151615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2015 |
| Decision Date | October 02, 2015 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |