K890054 is an FDA 510(k) clearance for the M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 8, 1989, 33 days after receiving the submission on January 6, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K890054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 06, 1989 |
| Decision Date | February 08, 1989 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |