K960023 is an FDA 510(k) clearance for the KIRSHNER WIRES (K-WIRE) & STEINMANN PINS. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Promex, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 18, 1996, 76 days after receiving the submission on January 2, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K960023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1996 |
| Decision Date | March 18, 1996 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |