Cleared Traditional

BIOPRO - INFINITY PLATE ANCHOR SYSTEM

K132510 · Biopro, Inc. · Orthopedic

Oct 2013

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K132510 is an FDA 510(k) clearance for the BIOPRO - INFINITY PLATE ANCHOR SYSTEM, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Biopro, Inc. (Prior Lake, US). The FDA issued a Cleared decision on October 24, 2013, 73 days after receiving the submission on August 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K132510 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 2013
Decision Date	October 24, 2013
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF