Cleared Traditional

K123948 - CHINA NAILS AND ACCESSORIES (FDA 510(k) Clearance)

K123948 · Smith & Nephew, Inc. · Orthopedic device

Mar 2013

Decision

83d

Days

Class 2

Risk

K123948 is an FDA 510(k) clearance for the CHINA NAILS AND ACCESSORIES. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 14, 2013, 83 days after receiving the submission on December 21, 2012.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K123948 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 2012
Decision Date	March 14, 2013
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF