K925301 is an FDA 510(k) clearance for the OTI ORTHOPEDIC FASTENER SYSTEM. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on March 16, 1993, 146 days after receiving the submission on October 21, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K925301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1992 |
| Decision Date | March 16, 1993 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HTY — Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |