The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Danek Wrist Fixator.
| Device ID | K891066 |
| 510k Number | K891066 |
| Device Name: | DANEK WRIST FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Contact | Frank M Lewis |
| Correspondent | Frank M Lewis DANEK MEDICAL, INC. 3092 DIRECTOR'S ROW Memphis, TN 38131 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-01 |
| Decision Date | 1989-08-28 |