FDA.reportPublic FDA data

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Primary DI
07899258658148
Brand
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Fix Super Max Zip Anchor
Catalog number
339-260-01
Device description
FIX SUPER MAX ZIP ANCHOR Ø2,6mm FIXED TAPE 2,0mm WHITE/BLACK SUTURE #5 WHITE/BLUE
Published
2024-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223114000Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsGm Dos Reis Industria E Comerico Ltda.2023-08-02MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258658148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258658148078992586581487899258658148

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
900865213
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899258654799Stitch - Suture Wires and Tapes333-239-AB1226CI2026-08-27
07899258654805Stitch - Suture Wires and Tapes333-239-PB1226CI2026-08-27
07899258654812Stitch - Suture Wires and Tapes333-20-B2026-08-27
07899258654829Stitch - Suture Wires and Tapes333-20-AB2026-08-27
07899258657141Stitch - Suture Wires and Tapes333-239-B1226CI2026-08-27
07899258665764Stitch - Suture Wires and Tapes333-536-AB1248CO2026-08-27
07899258665771Stitch - Suture Wires and Tapes333-536-B1248CO2026-08-27
07899258665795Stitch - Suture Wires and Tapes333-536-PB1248CO2026-08-27
07899258665863Stitch - Suture Wires and Tapes333-2-018-AB1226CI2026-08-27
07899258665870Stitch - Suture Wires and Tapes333-2-018-B1226CI2026-08-27
07899258665894Stitch - Suture Wires and Tapes333-2-018-PB1226CI2026-08-27
07899258665962Stitch - Suture Wires and Tapes333-13-AB2026-08-27
07899258665986Stitch - Suture Wires and Tapes333-13-B2026-08-27
07899258697864Stitch - Suture Wires and Tapes333-2-018-A1226CI2026-08-27
07899258697871Stitch - Suture Wires and Tapes333-2-090-AB1226CI2026-08-27
07899258697888Stitch - Suture Wires and Tapes333-2-090-PB1226CI2026-08-27
07899258697895Stitch - Suture Wires and Tapes333-2-090-B1226CI2026-08-27
07899258697901Stitch - Suture Wires and Tapes333-2-090-A1226CI2026-08-27
07899258698038Stitch - Suture Wires and Tapes333-239-A1226CI2026-08-27
07899258698045Stitch - Suture Wires and Tapes333-290-AB12265R2026-08-27

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Primary DI, Brand, Company table
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00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
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00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
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00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
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10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16