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FDA 510(k)

Versalock Periprosthetic Femur Plates System-GMReis

K-Number: K201728 · 2021-03-08

ApplicantGM Dos Reis Industria e Comercio Ltda.
Decision Date2021-03-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Versalock Periprosthetic Femur Plates System-GMReis is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2021-03-08 under 510(k) number K201728. 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 Versalock Periprosthetic Femur Plates System-GMReis?

Versalock Periprosthetic Femur Plates System-GMReis is a medical device that received FDA 510(k) clearance on 2021-03-08. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K201728.

When did Versalock Periprosthetic Femur Plates System-GMReis receive FDA 510(k) clearance?

Versalock Periprosthetic Femur Plates System-GMReis received FDA 510(k) clearance on 2021-03-08, under 510(k) number K201728.

Who is the listed applicant for Versalock Periprosthetic Femur Plates System-GMReis?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Versalock Periprosthetic Femur Plates System-GMReis?

The FDA product code for Versalock Periprosthetic Femur Plates System-GMReis is HRS.

Other records listing GM Dos Reis Industria e Comercio Ltda. 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.

K261406Versalock Proximal Tibial Plating SystemK260390Super Upper Limbs Versalock Plating SystemK254188Meniscus VersaflexK252664GMReis Suture AnchorsK243905Stitch Cerclage – Suture TapesK243740Versalock Upper Limb Plating 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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