The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for F-20 Cemented Metal-backed Acetabular Cup.
| Device ID | K901451 |
| 510k Number | K901451 |
| Device Name: | F-20 CEMENTED METAL-BACKED ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis, IN 46250 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling MED-TEK CORP. 6535 E. 82ND ST. SUITE 215 Indianapolis, IN 46250 |
| 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 | 1990-04-02 |
| Decision Date | 1990-08-31 |