The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Olive K-wires.
| Device ID | K903105 |
| 510k Number | K903105 |
| Device Name: | OLIVE K-WIRES |
| Classification | Component, Traction, Invasive |
| 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 | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-05 |
| Decision Date | 1990-09-06 |