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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 a medical device manufactured by GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2021-03-08 under approval 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. It is manufactured by GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K201728.

When was Versalock Periprosthetic Femur Plates System-GMReis approved by the FDA?

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

What company makes Versalock Periprosthetic Femur Plates System-GMReis?

Versalock Periprosthetic Femur Plates System-GMReis is manufactured by GM Dos Reis Industria e Comercio Ltda..

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.

Related Clinical Trials

NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED

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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

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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