Cleared Traditional

K050938 - KNEE FUSION NAIL (FDA 510(k) Clearance)

K050938 · Smith & Nephew, Inc. · Orthopedic device

May 2005

Decision

20d

Days

Class 2

Risk

K050938 is an FDA 510(k) clearance for the KNEE FUSION NAIL. 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 May 4, 2005, 20 days after receiving the submission on April 14, 2005.

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

Submission Details

510(k) Number	K050938 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 14, 2005
Decision Date	May 04, 2005
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF