K853259 is an FDA 510(k) clearance for the MALLORY/HEAD TOTAL HIP SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Composite/metal (Class II - Special Controls, product code KMC).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 1, 1985, 91 days after receiving the submission on August 2, 1985.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3340.
| 510(k) Number | K853259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 02, 1985 |
| Decision Date | November 01, 1985 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KMC — Prosthesis, Hip, Semi-constrained, Composite/metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3340 |