Cleared Traditional

LIFE SPINE CEMENT RESTRICTOR

K060247 · Life Spine · Orthopedic
May 2006
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K060247 is an FDA 510(k) clearance for the 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 May 11, 2006, 100 days after receiving the submission on January 31, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K060247 FDA.gov
FDA Decision Cleared SESU
Date Received January 31, 2006
Decision Date May 11, 2006
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDK — Prosthesis, Hip, Cement Restrictor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300

Similar Devices — JDK Prosthesis, Hip, Cement Restrictor

All 53
Mectaplug PE II
K210062 · Medacta International S.A. · Apr 2021
KMI CEMENT RESTRICTOR IMPLANT
K061465 · Kinetikos Medical, Inc. · Oct 2006
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
K061698 · Life Spine · Jul 2006
SPINAL USA CEMENT RESTRICTOR SYSTEM
K060132 · Spinal USA · Mar 2006
INTERBODY INNOVATIONS CEMENT RESTRICTOR
K051371 · Interbody Innovations, Llp · Dec 2005
SKELITE RESORBABLE CEMENT RESTRICTOR
K051836 · Millenium Biologix, Inc. · Nov 2005