K925607 is an FDA 510(k) clearance for the HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE. This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II - Special Controls, product code MEH).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 8, 1993, 368 days after receiving the submission on November 5, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K925607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | November 05, 1992 |
| Decision Date | November 08, 1993 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |