Cleared Traditional

BioPro Foot Plating Systems

K162674 · Biopro, Inc. · Orthopedic
Jun 2017
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K162674 is an FDA 510(k) clearance for the BioPro Foot Plating Systems, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on June 16, 2017, 263 days after receiving the submission on September 26, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K162674 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2016
Decision Date June 16, 2017
Days to Decision 263 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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