Cleared Traditional

K051836 - SKELITE RESORBABLE CEMENT RESTRICTOR
(FDA 510(k) Clearance)

K051836 · Millenium Biologix, Inc. · Orthopedic

Nov 2005

Decision

138d

Days

Class 2

Risk

K051836 is an FDA 510(k) clearance for the SKELITE RESORBABLE CEMENT RESTRICTOR. This device is classified as a Prosthesis, Hip, Cement Restrictor (Class II — Special Controls, product code JDK).

Submitted by Millenium Biologix, Inc. (West Cadwell, US). The FDA issued a Cleared decision on November 21, 2005, 138 days after receiving the submission on July 6, 2005.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K051836 FDA.gov
FDA Decision	Cleared SESU
Date Received	July 06, 2005
Decision Date	November 21, 2005
Days to Decision	138 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement