FDA.reportPublic FDA data

510(k) K242998

Device
GMReis Ankle Plating System
Applicant
GM Dos Reis Industria e Comercio Ltda.
510(k) number
K242998
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-21
Date received
2024-09-26
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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510(k), Device, Applicant table
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