FDA.reportPublic FDA data

VERSALOOP™ Anchor XL 1 Tape, 1.5mm

Primary DI
10818674025055
Brand
VERSALOOP™ Anchor XL 1 Tape, 1.5mm
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
210216
Catalog number
514377m
Published
2020-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K202178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202178000VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.2020-11-13MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818674025055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081867402505510818674025055

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
534123013
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
10810128461426Back Drill 4.5 X 7.0mmS25-3070-T145070su2026-07-22
10810128461440Back Drill 4.5 X 8.0mmS25-3080-T145080su2026-07-22
10810128461457Back Drill 4.5 X 8.5mmS25-3085-T145085su2026-07-22
10810128461464Back Drill 4.5 X 9.0mmS25-3090-T145090su2026-07-22
10810128461471Back Drill 4.5 x 9.5mmS25-3095-T145095su2026-07-22
10810128461488Back Drill 4.5 X 10.0mmS25-3100-T145100su2026-07-22
10810128463338Back Drill 6.0 X 11.0mmS25-3110-T160110su2026-07-22
10810128464137WireS25-3004-T146000su2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmAR-6593-57Q159o570ar2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmAR-6593-59Q159o590ar2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmAR-6593-77Q159o770ar2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmAR-6593-97Q159o970ar2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmAR-6593-99Q159o990ar2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmAR-6593DT159o90ar2026-07-21
10810128462782StayPort™ Cannula 5 mm x 7 cmAR-6593-05-07159570ar2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmAR-6593-05-09159590ar2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmAR-6593-07-07159770ar2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmAR-6593-07-09159790ar2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmAR-6593-09-07159970ar2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmAR-6593-09-09159990ar2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
10810128462966VersiTILT Button, 3.1x10.9mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-07-15
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