FDA.reportPublic FDA data

TopLock

Primary DI
00840124501331
Brand
TopLock
Company
FUSION ORTHOPEDICS, LLC
Model
TP-AN-3501
Catalog number
TP-AN-3501
Device description
Threaded Suture Anchor 3.5 mm
Published
2020-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124501331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124501331008401245013318401245013310840124501331

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124526037FuzeFix MiniTN-TR-0099TN-TR-00992026-07-07
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810155331412Tigon MedicalTigon Medical LLCMBI2026-07-09
00850029805106Tigon MedicalTigon Medical LLCMBI2026-06-26
07901125601130GMReis Suture AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDAMBI2026-06-25
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
00888867465220Arthrex®ARTHREX, INC.MBI2025-06-23
00888867465237Arthrex®ARTHREX, INC.MBI2025-06-23
00888867465244Arthrex®ARTHREX, INC.MBI2025-06-23
00888867501324Arthrex®ARTHREX, INC.MBI2025-06-23