Cleared Traditional

K130986 - FRAG-LOC SYSTEM (FDA 510(k) Clearance)

K130986 · Acumed, LLC · Orthopedic device

Jul 2013

Decision

105d

Days

Class 2

Risk

K130986 is an FDA 510(k) clearance for the FRAG-LOC SYSTEM. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).

Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on July 23, 2013, 105 days after receiving the submission on April 9, 2013.

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

Submission Details

510(k) Number	K130986 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 09, 2013
Decision Date	July 23, 2013
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF