K936044 is an FDA 510(k) clearance for the ENHANCED MODULAR AUSTIN MOORE HIP. This device is classified as a Prosthesis, Hip, Semi-constrained, Composite/metal (Class II - Special Controls, product code KMC).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 26, 1994, 127 days after receiving the submission on December 20, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3340.
| 510(k) Number | K936044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1993 |
| Decision Date | April 26, 1994 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KMC — Prosthesis, Hip, Semi-constrained, Composite/metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3340 |