K884889 is an FDA 510(k) clearance for the MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 27, 1989, 97 days after receiving the submission on November 22, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K884889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1988 |
| Decision Date | February 27, 1989 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |