Cleared Traditional

K150889 - Suture Wires and Wire Loops (FDA 510(k) Clearance)

K150889 · Zimmer, Inc. · Orthopedic device

Jul 2015

Decision

90d

Days

Class 2

Risk

K150889 is an FDA 510(k) clearance for the Suture Wires and Wire Loops. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 1, 2015, 90 days after receiving the submission on April 2, 2015.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K150889 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 02, 2015
Decision Date	July 01, 2015
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF