K053319 is an FDA 510(k) clearance for the ALLOMATRIX CUSTOM. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 6, 2006, 96 days after receiving the submission on November 30, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K053319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2005 |
| Decision Date | March 06, 2006 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |