The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Brooker External Fixation Frame.
| Device ID | K840286 |
| 510k Number | K840286 |
| Device Name: | BROOKER EXTERNAL FIXATION FRAME |
| Classification | Pin, Fixation, Threaded |
| Applicant | DEPUY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-02-09 |