K915548 is an FDA 510(k) clearance for the IONGUARD TITANIUM MODULAR HEADS. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II - Special Controls, product code LZY).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 10, 1992, 90 days after receiving the submission on December 11, 1991.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K915548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1991 |
| Decision Date | March 10, 1992 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |