K031961 is an FDA 510(k) clearance for the INION OTPS BIODEGRADABLE MESH PLATING SYSTEM. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on March 1, 2004, 250 days after receiving the submission on June 25, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K031961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2003 |
| Decision Date | March 01, 2004 |
| Days to Decision | 250 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 |