K053642 is an FDA 510(k) clearance for the OSTEOSET DBM PELLETS. This device is classified as a Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (Class II - Special Controls, product code MBP).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on January 26, 2006, 27 days after receiving the submission on December 30, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K053642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2005 |
| Decision Date | January 26, 2006 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBP — Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |