The following data is part of a premarket notification filed by Implant Resource, Inc. with the FDA for Pins And Wires.
| Device ID | K002125 |
| 510k Number | K002125 |
| Device Name: | PINS AND WIRES |
| Classification | Pin, Fixation, Smooth |
| Applicant | IMPLANT RESOURCE, INC. 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott IMPLANT RESOURCE, INC. 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2000-10-11 |