The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Km-2 Metal-backed Acetabular Cup.
| Device ID | K844319 |
| 510k Number | K844319 |
| Device Name: | KM-2 METAL-BACKED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-06 |
| Decision Date | 1985-09-19 |