Cleared Traditional

MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT

K103233 · Howmedica Osteonics Corp. · Orthopedic

Feb 2011

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K103233 is an FDA 510(k) clearance for the MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on February 3, 2011, 93 days after receiving the submission on November 2, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K103233 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2010
Decision Date	February 03, 2011
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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