K062173 is an FDA 510(k) clearance for the MODIFICATION TO BONE GRAFT SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 23, 2006, 23 days after receiving the submission on July 31, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K062173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2006 |
| Decision Date | August 23, 2006 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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 |