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Data / Medical devices / Brazil / Ortoface Cosmeticos E Produtos Para Saude Ltda

Ortoface Cosmeticos E Produtos Para Saude Ltda: FDA-registered device maker in Salto Sao Paulo, Brazil, 21 510(k) clearances

Ortoface Cosmeticos E Produtos Para Saude Ltda is registered with the FDA (registration 3043620689) in Salto Sao Paulo, Brazil. It lists 21 device types. The FDA files 21 510(k) clearances under its listings, the newest dated August 22, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ortoface Cosmeticos E Produtos Para Saude Ltda
FDA registration number
3043620689
Address
Rua Rodrigues Alves, 505 Centro, Salto Sao Paulo, Brazil, 13320130
Owner or operator
GM dos Reis Industria e Comercio Ltda (10059832)
Roles
Exporter to the US
First device listed
February 27, 2019
Registered through
2026
Brand names listed
312-500 - MULTICUTTER - Arthroscopic Retrograde Drill, 335-100 - MICRO EASYPASS - STRAIGHT MICRO SUTURE PASSER, 335-200 - MICRO EASYPASS - SMALL CURVED MICRO SUTURE PASSER, 335-300 - MICRO EASYPASS - LARGE CURVED MICRO SUTURE PASSER, 335-600 - MICRO EASYPASS - EXTRA LARGE CURVED MICRO SUTURE PASSER, 335-99 - MICRO EASYPASS - SHORT CURVED MICRO SUTURE PASS, 354-100-050 - Meniscus Suture - OUT IN, 359-200 - ACCESS FIT – STRAIGHT SUTURE PASSER and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Exporter to the USaccessdata.fda.gov
Burr, OrthopedicHTT1Exporter to the USaccessdata.fda.gov
Cerclage, FixationJDQ2Exporter to the USaccessdata.fda.gov
Condylar Plate Fixation ImplantJDP2Exporter to the USaccessdata.fda.gov
ExtractorHWB1Exporter to the USaccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Exporter to the USaccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentKIJ1Exporter to the USaccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Exporter to the USaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the USaccessdata.fda.gov
PasserHWQ1Exporter to the USaccessdata.fda.gov
Plate, Fixation, BoneHRS2Exporter to the USaccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Exporter to the USaccessdata.fda.gov
Screw, Fixation, BoneHWC2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Exporter to the USaccessdata.fda.gov
TemplateHWT1Exporter to the USaccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Washer, Bolt NutHTN2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 22, 2026K253910Stitch - Suture Wires and TapesGATSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
August 19, 2026K262537Versalock Sterile Plating SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
July 21, 2026K261406Versalock Proximal Tibial Plating SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
March 17, 2026K260390Super Upper Limbs Versalock Plating SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
February 19, 2026K254188Meniscus VersaflexGATSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
December 19, 2025K251050Pectus Versa SystemHRSSubstantially EquivalentGm Dos Reis Industria E Comercioaccessdata.fda.gov
November 4, 2025K252664GMReis Suture AnchorsMBISubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
August 14, 2025K243905Stitch Cerclage – Suture TapesJDQSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
June 12, 2025K250559GMReis Fibula Nail SystemHSBSubstantially EquivalentGm Dos Reis Industria E Comercioaccessdata.fda.gov
January 29, 2025K243740Versalock Upper Limb Plating SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
November 21, 2024K242998GMReis Ankle Plating SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
November 21, 2024K242596Versalock Mini and Micro Plating SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
November 1, 2024K242311EXPERT - Flexible Joint Fixation SystemHTNSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
June 26, 2024K232829Versalock Rib and Sternum Plates SystemHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
January 12, 2024K231684Quick - Radius Disposable SetHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
August 2, 2023K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsMBISubstantially EquivalentGm Dos Reis Industria E Comerico Ltda.accessdata.fda.gov
June 12, 2023K230397Cut Screw - Percutaneous Compression ScrewHWCSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
March 8, 2021K201728Versalock Periprosthetic Femur Plates System-GMReisHRSSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
October 29, 2020K200332EXPERT - Joint Fixation SystemHTNSubstantially EquivalentGM Dos Reis Industria e Comercio Ltda.accessdata.fda.gov
December 23, 2019K182718Mini and Micro Fragments Reconstruction System – GMReisHRSSubstantially EquivalentGm Dos Reis Industria E Comerico Ltda.accessdata.fda.gov
February 1, 2019K180626Pedimax II - Pedicular Screw Spinal SystemNKBSubstantially EquivalentGm Dos Reis Industria E Comerico Ltda.accessdata.fda.gov

Compare with other makers

Updated August 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.