The following data is part of a premarket notification filed by Pacific Instruments with the FDA for Pacific Instruments Orthopedic Fixation Pins And Wires / Kirschner / Guide Wires.
| Device ID | K213982 |
| 510k Number | K213982 |
| Device Name: | Pacific Instruments Orthopedic Fixation Pins And Wires / Kirschner / Guide Wires |
| Classification | Pin, Fixation, Smooth |
| Applicant | Pacific Instruments 438 Hobron Ln, Ste 204 Honolulu, HI 96815 |
| Contact | Tracy Sullivan |
| Correspondent | Jared Walkenhorst Novare Medical Consulting LLC. 1765 Dusty Boot Dr. Lafayette, CO 80026 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-02-17 |