K072330 is an FDA 510(k) clearance for the CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 6, 2007, 108 days after receiving the submission on August 20, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K072330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2007 |
| Decision Date | December 06, 2007 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |