FDA.report

510(k) K252664

Device
GMReis Suture Anchors
Applicant
GM Dos Reis Industria e Comercio Ltda.
510(k) number
K252664
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-04
Date received
2025-08-22
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

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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