FDA.reportPublic FDA data

TopLock

Primary DI
00840124511644
Brand
TopLock
Company
FUSION ORTHOPEDICS, LLC
Model
TP-KL-1000-S
Device description
3.5mm Knotless Anchor Implant Kit
Published
2024-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124511644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124511644008401245116448401245116440840124511644

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
080307067
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525474PolyLock MidfootMF-LK-2748MF-LK-27482026-03-10
00840124525481PolyLock MidfootMF-NL-2748MF-NL-27482026-03-10
00840124525450Depth GaugeTN-DG-8000TN-DG-80002026-03-06
00840124525375FuzeFix Max FTFX-FT-2532-SFX-FT-2532-S2026-02-17
00840124525382FuzeFix Max FTFX-FT-2534-SFX-FT-2534-S2026-02-17
00840124525399FuzeFix Max FTFX-FT-2536-SFX-FT-2536-S2026-02-17
00840124525405FuzeFix Max FTFX-FT-2538-SFX-FT-2538-S2026-02-17
00840124525412FuzeFix Max FTFX-FT-2542-SFX-FT-2542-S2026-02-17
00840124525429FuzeFix Max FTFX-FT-2544-SFX-FT-2544-S2026-02-17
00840124525436FuzeFix Max FTFX-FT-2546-SFX-FT-2546-S2026-02-17
00840124525443FuzeFix Max FTFX-FT-2548-SFX-FT-2548-S2026-02-17
00840124525320FuzeFix MiniTN-FX-6012TN-FX-60122026-02-03
00840124525337FuzeFix MiniTN-FX-6013TN-FX-60132026-02-03
00840124525344Metalogix RevolutionTN-TR-0095TN-TR-00952026-02-03
00840124525351Metalogix RevolutionTN-TR-0094TN-TR-00942026-02-03
00840124525368Metalogix RevolutionTN-TR-0090TN-TR-00902026-02-03
00840124525245FuzeFix MiniTN-FX-6011TN-FX-60112026-01-22
00840124525252Metalogix RevolutionTN-TR-0091TN-TR-00912026-01-22
00840124525269Metalogix RevolutionMX-RP-0120MX-RP-01202026-01-22
00840124525276Metalogix RevolutionMX-RP-0140MX-RP-01402026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277405609LigaMend™ (Black)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405616LigaMend™ (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405623LigaMend™RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405630Strut SutureRIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405715LigaMend™ Soft Button (Black)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405722LigaMend™ Soft Button (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277411358No-Tie ButtonRIVERPOINT MEDICAL, LLCMBI2026-03-19
10888867550817Arthrex®ARTHREX, INC.MBI2026-03-12
00888867550827Arthrex®ARTHREX, INC.MBI2026-03-12
00860013967000RapidFix™ All-Suture Dual AnchorSuture Tech, Inc.MBI2026-03-09
00888867569638Arthrex®ARTHREX, INC.MBI2026-03-04
00888867569645Arthrex®ARTHREX, INC.MBI2026-03-04
00888867569652Arthrex®ARTHREX, INC.MBI2026-03-04
00888867573130Arthrex®ARTHREX, INC.MBI2026-03-04
00812444029673OrthoButton ALRIVERPOINT MEDICAL, LLCMBI2026-03-03
00889024706323Jgrknt Large 2.9mm Reusable TrocarZimmer, Inc.MBI2026-02-23
00889024706330Jgrknt Large 2.9mm Reusable GuideZimmer, Inc.MBI2026-02-23
00888867470149Arthrex®ARTHREX, INC.MBI2026-02-08
00888867470170Arthrex®ARTHREX, INC.MBI2026-02-08
00888867593138Arthrex®ARTHREX, INC.MBI2026-02-08
30653405546508Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
30653405990721Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
00810155330989Tigon MedicalTigon Medical LLCMBI2026-02-04
00810155331214Tigon MedicalTigon Medical LLCMBI2026-02-04
00810155331276Tigon MedicalTigon Medical LLCMBI2026-01-23
00888867520745Arthrex®ARTHREX, INC.MBI2026-01-21
08903993499856AUXILOCK PEEK OPTIMA Screw-In Suture AnchorAuxein Medical Private LimitedMBI2026-01-20
28437019739748QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
28437019739755QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
28437019739762QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14