FDA.reportPublic FDA data

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Primary DI
07899258658001
Brand
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Mini Zip Anchor
Catalog number
339-120-01
Device description
MINI ZIP ANCHOR Ø1,2mm SUTURE #1 WHITE/BLUE
Published
2024-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
07899258658001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258658001078992586580017899258658001

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
07901125609020Orthopedic InstrumentsVERSALOCK ANKLE SYSTEM BOX - FOR USA314-70102026-08-17
07899258663241ACCESS FITSTRAIGHT SUTURE PASSER359-2002024-08-13
07899258663258ACCESS FITRIGHT SUTURE PASSER359-2102024-08-13
07899258663265ACCESS FITLEFT SUTURE PASSER359-2202024-08-13
07899258658292Meniscus Suture - OUT INMeniscus Suture - OUT IN354-100-0502024-01-18
07899258606637Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x10.0mm169-35-102026-07-30
07899258606644Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x12.0mm169-35-122026-07-30
07899258606651Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x14.0mm169-35-142026-07-30
07899258606668Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x16.0mm169-35-162026-07-30
07899258606675Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x18.0mm169-35-182026-07-30
07899258606682Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x20.0mm169-35-202026-07-30
07899258606699Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x22.0mm169-35-222026-07-30
07899258606705Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x24.0mm169-35-242026-07-30
07899258606712Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x26.0mm169-35-262026-07-30
07899258606729Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x28.0mm169-35-282026-07-30
07899258606736Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x30.0mm169-35-302026-07-30
07899258606743Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x32.0mm169-35-322026-07-30
07899258606750Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x34.0mm169-35-342026-07-30
07899258606767Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x35.0mm169-35-352026-07-30
07899258606774Versalock Proximal Tibial Plating SystemCANCELLOUS SCREW Ø3.5x36.0mm169-35-362026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
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
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
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
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16