FDA.reportPublic FDA data

510(k) K243740

Device
Versalock Upper Limb Plating System
Applicant
GM Dos Reis Industria e Comercio Ltda.
510(k) number
K243740
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-29
Date received
2024-12-04
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Guilherme Esteves Pontes
Address
Avenida Pierre Simon De Laplace, 600 Campinas BR 13069320 13069320

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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