The following data is part of a premarket notification filed by Precifit Medical Ltd with the FDA for Precifit Medical Kirschner Wires.
| Device ID | K163327 |
| 510k Number | K163327 |
| Device Name: | Precifit Medical Kirschner Wires |
| Classification | Pin, Fixation, Smooth |
| Applicant | PRECIFIT MEDICAL LTD 951 AVIATION PKWY STE 100 Morrisville, NC 27560 |
| Contact | Zhen Yu(eric) Wu |
| Correspondent | Kellen Hills ORCHID DESIGN 4600 E SHELBY DR Memphis, TN 38118 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-28 |
| Decision Date | 2017-05-08 |
| Summary: | summary |