The following data is part of a premarket notification filed by Protek, Inc. with the FDA for M.e.m. Acetabular Cup W/sulmesh For Cement Appli..
| Device ID | K890054 |
| 510k Number | K890054 |
| Device Name: | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
| Contact | D Nikolaev |
| Correspondent | D Nikolaev PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
| 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 | 1989-01-06 |
| Decision Date | 1989-02-08 |