Cleared Traditional

Metallic Locking Bone Plate and Screw

K142943 · Canwell Medical Co., Ltd. · Orthopedic

Aug 2015

Decision

297d

Days

Class 2

Risk

About This 510(k) Submission

K142943 is an FDA 510(k) clearance for the Metallic Locking Bone Plate and Screw, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Canwell Medical Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on August 3, 2015, 297 days after receiving the submission on October 10, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K142943 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2014
Decision Date	August 03, 2015
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF