The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Orthopedic Wire, Eyelet Cerclage Wires.
| Device ID | K850631 |
| 510k Number | K850631 |
| Device Name: | KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES |
| Classification | Cerclage, Fixation |
| Applicant | KIRSCHNER MEDICAL CORP. MANAGER PRO TEM 4230 TRENTON LANE Plymouth, MN 55441 |
| Contact | Karen A Young |
| Correspondent | Karen A Young KIRSCHNER MEDICAL CORP. MANAGER PRO TEM 4230 TRENTON LANE Plymouth, MN 55441 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-05-01 |