K072432 is an FDA 510(k) clearance for the F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 9, 2008, 133 days after receiving the submission on August 29, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K072432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2007 |
| Decision Date | January 09, 2008 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC - Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |