K123672 is an FDA 510(k) clearance for the INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW). This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on February 27, 2013, 90 days after receiving the submission on November 29, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K123672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2012 |
| Decision Date | February 27, 2013 |
| Days to Decision | 90 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 |