Cleared Traditional

K043252 - CABLING SYSTEM TROCHANTER HOOK (FDA 510(k) Clearance)

K043252 · Smith & Nephew, Inc. · Orthopedic device

Jan 2005

Decision

52d

Days

Class 2

Risk

K043252 is an FDA 510(k) clearance for the CABLING SYSTEM TROCHANTER HOOK. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on January 14, 2005, 52 days after receiving the submission on November 23, 2004.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K043252 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 23, 2004
Decision Date	January 14, 2005
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF