FDA.report

510(k) K223114

Device
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Applicant
Gm Dos Reis Industria E Comerico Ltda.
510(k) number
K223114
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-02
Date received
2022-10-03
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
Iara Guimaraes
Address
Avenida Pierre Simon De La Pl. 600 Campinas BR 13069320 13069320

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
07899258658735Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-15
07899258657967Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658650Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658025Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258657134Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258656298Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258657950Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258657981Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258657998Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658001Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658018Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258657974Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658124Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658131Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658148Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658155Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658162Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658179Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658186Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658193Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658209Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658216Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658223Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658599Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658605Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658612Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658629Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658636Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658643Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12
07899258658667Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDA2024-01-12

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