K050275 is an FDA 510(k) clearance for the MODIFICATION TO: INION OTPS BIODEGRADABLE PIN. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on March 7, 2005, 28 days after receiving the submission on February 7, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K050275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2005 |
| Decision Date | March 07, 2005 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY — Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |