510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GM dos Reis Industria e Comercio Ltda

Campinas Sao Paulo, BR

GM DOS REIS INDUSTRIA E COMERCIO LTDA appears in FDA device records in Campinas Sao Paulo, BR. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 14 510(k) clearances for GM dos Reis Industria e Comercio Ltda between 2020 and 2026. The busiest year on record is 2024, with 5. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for GM dos Reis Industria e Comercio Ltda, by decision year
YearClearances
20201
20211
20231
20245
20253
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261406Versalock Proximal Tibial Plating SystemHRSSubstantially Equivalent
K260390Super Upper Limbs Versalock Plating SystemHRSSubstantially Equivalent
K254188Meniscus VersaflexGATSubstantially Equivalent
K252664GMReis Suture AnchorsMBISubstantially Equivalent
K243905Stitch Cerclage – Suture TapesJDQSubstantially Equivalent
K243740Versalock Upper Limb Plating SystemHRSSubstantially Equivalent
K242998GMReis Ankle Plating SystemHRSSubstantially Equivalent
K242596Versalock Mini and Micro Plating SystemHRSSubstantially Equivalent
K242311EXPERT - Flexible Joint Fixation SystemHTNSubstantially Equivalent
K232829Versalock Rib and Sternum Plates SystemHRSSubstantially Equivalent
K231684Quick - Radius Disposable SetHRSSubstantially Equivalent
K230397Cut Screw - Percutaneous Compression ScrewHWCSubstantially Equivalent
K201728Versalock Periprosthetic Femur Plates System-GMReisHRSSubstantially Equivalent
K200332EXPERT - Joint Fixation SystemHTNSubstantially Equivalent

Registered establishments

FDA registered establishments for GM dos Reis Industria e Comercio Ltda, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30137561693013756169GM DOS REIS INDUSTRIA E COMERCIO LTDAAvenida Pierre Simon de La Place, 600, Campinas Sao Paulo 13069320 BR2026and 11 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain