Cleared Traditional

K051371 - INTERBODY INNOVATIONS CEMENT RESTRICTOR
(FDA 510(k) Clearance)

K051371 · Interbody Innovations, Llp · Orthopedic

Dec 2005

Decision

194d

Days

Class 2

Risk

K051371 is an FDA 510(k) clearance for the INTERBODY INNOVATIONS CEMENT RESTRICTOR, a Prosthesis, Hip, Cement Restrictor (Class II — Special Controls, product code JDK), submitted by Interbody Innovations, Llp (Clearwater, US). The FDA issued a Cleared decision on December 6, 2005, 194 days after receiving the submission on May 26, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K051371 FDA.gov
FDA Decision	Cleared SESU
Date Received	May 26, 2005
Decision Date	December 06, 2005
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF