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FDA 510(k)

PolyLock Plating System

K-Number: K211843 · 2022-03-04

ApplicantFusion Orthopedics
Decision Date2022-03-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PolyLock Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics. It received FDA 510(k) clearance on 2022-03-04 under 510(k) 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. The listed applicant is Fusion Orthopedics. The 510(k) number is K211843.

When did PolyLock Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for PolyLock Plating System?

The FDA 510(k) record lists Fusion Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PolyLock Plating System?

The FDA product code for PolyLock Plating System is HRS.

Other records listing Fusion Orthopedics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242091Bolo Button SystemK210159IntraLock SystemK193377TopLock Anchor SystemK202959PolyLock Plating SystemK192323PolyLock Small Bone Plating SystemK190136Fusion Silastic System

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

View on FDA Database →

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

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