FDA 510(k)

BioPro Foot Plating Systems

K-Number: K162674 · 2017-06-16

Decision Date2017-06-16

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BioPro Foot Plating Systems is a medical device manufactured by Biopro, Inc.. It received FDA 510(k) clearance on 2017-06-16 under approval number K162674. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioPro Foot Plating Systems?

BioPro Foot Plating Systems is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Biopro, Inc.. The 510(k) number is K162674.

When was BioPro Foot Plating Systems approved by the FDA?

BioPro Foot Plating Systems received FDA 510(k) clearance on 2017-06-16, under approval number K162674.

What company makes BioPro Foot Plating Systems?

BioPro Foot Plating Systems is manufactured by Biopro, Inc..

What is the FDA product code for BioPro Foot Plating Systems?

The FDA product code for BioPro Foot Plating Systems is HRS.

Other Devices by Biopro, Inc.

K163627Shotel Ankle Arthrodesis Nail System

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.