FDA.reportPublic FDA data

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Primary DI
07899258658827
Brand
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Max Zip Anchor
Catalog number
39-190-08
Device description
MAX ZIP ANCHOR Ø1,9mm 2 SUTURES #2 WHITE AND WHITE/BLUE 4 NEEDLES 26mm 1/2 CIRCLE CYLINDER TIP
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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

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
07899258658827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258658827078992586588277899258658827

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
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
07899258695846Meniscus VersaflexMeniscus Versaflex354-3002026-03-03
07901125601062Meniscus VersaflexMeniscus Versaflex - Reverse354-4002026-03-03
07899258602011Orthopedic InstrumentsTHREADED OLIVE WIRE Ø1.2x60.0mm308-9152026-02-26
07901125601079Orthopedic InstrumentsCASE - COMPRESSION PLATES IMPLANTS AND INSTRUMENTS308-ES-FU2026-02-26
07899258602028Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø1,5MM308-9032026-02-20
07899258602035Orthopedic InstrumentsGRADUATED POLYAXIAL DRILL GUIDE Ø2,0MM308-9092026-02-20
07899258638973Orthopedic InstrumentsBACAUS CANNULATED FORCEPS900-1502026-02-20
07899258639062Orthopedic InstrumentsPeriostum 4.0mm Straight Tip900-992026-02-20
07899258648057Orthopedic InstrumentsHOHMANN SEPARATOR 8.0mm900-1012026-02-20
07899258660912Orthopedic Instruments4.5 Hex Wrench353-109-10342026-02-20
07899258660929Orthopedic InstrumentsHex wrench 4.0353-109-10352026-02-20
07899258660936Orthopedic Instruments3.5 hex wrench353-109-10362026-02-20
07899258660943Orthopedic InstrumentsHex wrench 3.0353-109-10372026-02-20
07899258660950Orthopedic Instruments2.5 Hex Wrench353-109-10382026-02-20
07899258660967Orthopedic InstrumentsHex wrench 2.0353-109-10392026-02-20
07899258660974Orthopedic InstrumentsHex wrench 1.5353-109-10402026-02-20
07899258660981Orthopedic Instruments5.0 Hex wrench353-109-10332026-02-20
07899258660998Orthopedic Instruments5.5 Hex Wrench353-109-10322026-02-20
07899258694702Orthopedic InstrumentsTorxdrive Wrench T20353-109-10222026-02-20
07899258694719Orthopedic InstrumentsTorxdrive Wrench T18353-109-10232026-02-20

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