K132911 is an FDA 510(k) clearance for the I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by In2bones Sas (France, FR). The FDA issued a Cleared decision on April 4, 2014, 199 days after receiving the submission on September 17, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K132911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2013 |
| Decision Date | April 04, 2014 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |