Cleared Special

RESTORATION ADM SYSTEM X3 ACETABULAR

K093644 · Howmedica Osteonics Corp. · Orthopedic

Dec 2009

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K093644 is an FDA 510(k) clearance for the RESTORATION ADM SYSTEM X3 ACETABULAR, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on December 18, 2009, 23 days after receiving the submission on November 25, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K093644 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2009
Decision Date	December 18, 2009
Days to Decision	23 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353