K932348 is an FDA 510(k) clearance for the ORTHOPEDIC SMOOTH PIN FIXATION. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Osteomed Corp. (Fort Wayne, US). The FDA issued a Cleared decision on March 1, 1994, 291 days after receiving the submission on May 14, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K932348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1993 |
| Decision Date | March 01, 1994 |
| Days to Decision | 291 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 |