Cleared Traditional

JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS

K141219 · Biomet Manufacturing Corp · Orthopedic

Jul 2014

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K141219 is an FDA 510(k) clearance for the JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 18, 2014, 67 days after receiving the submission on May 12, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K141219 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2014
Decision Date	July 18, 2014
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF