The following data is part of a premarket notification filed by Westcon Orthopedics, Inc. with the FDA for K-cape Orthopedic Wires And Pins.
| Device ID | K901525 |
| 510k Number | K901525 |
| Device Name: | K-CAPE ORTHOPEDIC WIRES AND PINS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WESTCON ORTHOPEDICS, INC. P.O. BOX 337 Three Bridges, NJ 08887 |
| Contact | Donn M Gordon |
| Correspondent | Donn M Gordon WESTCON ORTHOPEDICS, INC. P.O. BOX 337 Three Bridges, NJ 08887 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-02 |
| Decision Date | 1990-04-23 |