The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Kirshner Wires (k-wire) & Steinmann Pins.
| Device ID | K960023 |
| 510k Number | K960023 |
| Device Name: | KIRSHNER WIRES (K-WIRE) & STEINMANN PINS |
| Classification | Pin, Fixation, Threaded |
| Applicant | PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-03-18 |