Cleared Special

K090103: 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL

K090103 · Biomet, Inc. · Orthopedic
Feb 2009
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K090103 is an FDA 510(k) clearance for the 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (Class II — Special Controls, product code MAY), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 11, 2009, 27 days after receiving the submission on January 15, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K090103 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2009
Decision Date February 11, 2009
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAY — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3353