K011726 is an FDA 510(k) clearance for the MILLENIUM'S SKELITE SYNTHETIC RESORBABLE BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Millenium Biologix, Inc. (West Cadwell, US). The FDA issued a Cleared decision on May 16, 2002, 346 days after receiving the submission on June 4, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K011726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2001 |
| Decision Date | May 16, 2002 |
| Days to Decision | 346 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | MQV — Filler, Bone Void, Calcium Compound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3045 |