K161568 is an FDA 510(k) clearance for the Bone Solutions Mixing and Delivery System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on September 16, 2016, 101 days after receiving the submission on June 7, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K161568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2016 |
| Decision Date | September 16, 2016 |
| Days to Decision | 101 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 |