FDA.reportPublic FDA data

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
No

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

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510(k), Device, Applicant table
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K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.2026-03-02
K253695LigaMendRiverpoint Medical, LLC2026-02-27