Cleared Traditional

K060132 - SPINAL USA CEMENT RESTRICTOR SYSTEM
(FDA 510(k) Clearance)

K060132 · Spinal USA · Orthopedic

Mar 2006

Decision

57d

Days

Class 2

Risk

K060132 is an FDA 510(k) clearance for the SPINAL USA CEMENT RESTRICTOR SYSTEM, a Prosthesis, Hip, Cement Restrictor (Class II — Special Controls, product code JDK), submitted by Spinal USA (Brandon, US). The FDA issued a Cleared decision on March 16, 2006, 57 days after receiving the submission on January 18, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K060132 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2006
Decision Date	March 16, 2006
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF