Cleared Traditional

K013430 - ACE BIO WIN TIBIAL NAILING SYSTEM (FDA 510(k) Clearance)

K013430 · DePuy Orthopaedics, Inc. · Orthopedic device

Dec 2001

Decision

62d

Days

Class 2

Risk

K013430 is an FDA 510(k) clearance for the ACE BIO WIN TIBIAL NAILING SYSTEM. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 2001, 62 days after receiving the submission on October 16, 2001.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K013430 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 16, 2001
Decision Date	December 17, 2001
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF