K152077 is an FDA 510(k) clearance for the MaxiGen. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).
Submitted by Hans Biomed Corp. (Daejeon, KR). The FDA issued a Cleared decision on April 21, 2016, 269 days after receiving the submission on July 27, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.
| 510(k) Number | K152077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2015 |
| Decision Date | April 21, 2016 |
| Days to Decision | 269 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 |