K122310 is an FDA 510(k) clearance for the GEMINUS FOSSA SPECIFIC PLATE SYSTEM. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on January 18, 2013, 170 days after receiving the submission on August 1, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K122310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2012 |
| Decision Date | January 18, 2013 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |