Cleared Traditional

IONGUARD TITANIUM MODULAR HEADS

K915548 · Biomet, Inc. · Orthopedic
Mar 1992
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K915548 is an FDA 510(k) clearance for the IONGUARD TITANIUM MODULAR HEADS, 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 review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K915548 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360