Cleared Special

K061698 - MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
(FDA 510(k) Clearance)

K061698 · Life Spine · Orthopedic

Jul 2006

Decision

26d

Days

Class 2

Risk

K061698 is an FDA 510(k) clearance for the MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR, a Prosthesis, Hip, Cement Restrictor (Class II — Special Controls, product code JDK), submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on July 12, 2006, 26 days after receiving the submission on June 16, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K061698 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2006
Decision Date	July 12, 2006
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF