Cleared Traditional

K163034 - SUTUREFIX Curved Suture Anchor (FDA 510(k) Clearance)

K163034 · Smith and Nephew, Inc. · Orthopedic device

Dec 2016

Decision

37d

Days

Class 2

Risk

K163034 is an FDA 510(k) clearance for the SUTUREFIX Curved Suture Anchor. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).

Submitted by Smith and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on December 7, 2016, 37 days after receiving the submission on October 31, 2016.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K163034 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 31, 2016
Decision Date	December 07, 2016
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF