FDA 510(k)

PolyLock Plating System

K-Number: K211843 · 2022-03-04

Decision Date2022-03-04

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PolyLock Plating System is a medical device manufactured by Fusion Orthopedics. It received FDA 510(k) clearance on 2022-03-04 under approval number K211843. 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 PolyLock Plating System?

PolyLock Plating System is a medical device that received FDA 510(k) clearance on 2022-03-04. It is manufactured by Fusion Orthopedics. The 510(k) number is K211843.

When was PolyLock Plating System approved by the FDA?

PolyLock Plating System received FDA 510(k) clearance on 2022-03-04, under approval number K211843.

What company makes PolyLock Plating System?

PolyLock Plating System is manufactured by Fusion Orthopedics.

What is the FDA product code for PolyLock Plating System?

The FDA product code for PolyLock Plating System is HRS.

Other Devices by Fusion Orthopedics

K242091Bolo Button 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.