The following data is part of a premarket notification filed by Warsaw Orthopedic, Inc. with the FDA for Partially Threaded Bone Fix. Pin.
Device ID | K842293 |
510k Number | K842293 |
Device Name: | PARTIALLY THREADED BONE FIX. PIN |
Classification | Pin, Fixation, Threaded |
Applicant | WARSAW ORTHOPEDIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-13 |
Decision Date | 1984-08-02 |