K925345 is an FDA 510(k) clearance for the ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM). This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II - Special Controls, product code LZO).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 10, 1994, 504 days after receiving the submission on October 22, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K925345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 22, 1992 |
| Decision Date | March 10, 1994 |
| Days to Decision | 504 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |