FDA.reportPublic FDA data

Integrity Orthopaedics

Primary DI
00860009782204
Brand
Integrity Orthopaedics
Company
Integrity Orthopaedics, Inc
Model
901001
Catalog number
901001
Device description
Integrity Orthopaedics Anchor Array, included with Anchor Array System Kit.
Published
2023-02-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009782204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009782204008600097822048600097822040860009782204

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)].

Regulatory Flags#

DUNS number
118804591
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015538208Integrity Orthopaedics72205994722059942026-04-20
00860015538215Integrity Orthopaedics2010012010012026-04-20
00860015538222Integrity Orthopaedics72205995722059952026-04-20
00860015538239Integrity Orthopaedics2020012020012026-04-20
00860015538246Integrity Orthopaedics72205996722059962026-04-20
00860015538253Integrity Orthopaedics2010292010292026-04-20
00860015538260Integrity Orthopaedics72205997722059972026-04-20
00860015538277Integrity Orthopaedics2020012020012026-04-20
00860009782235Integrity Orthopaedics9010029010022023-02-13
00860009782211Integrity Orthopaedics9020019020012023-02-13
00860009782228Integrity Orthopaedics9010039010032023-02-13
00860013905910Integrity Orthopaedics9010019010012025-05-16
00860013905927Integrity Orthopaedics9020019020012025-05-16
00860013905934Integrity Orthopaedics9010039010032025-05-16
00860013905941Integrity Orthopaedics9010029010022025-05-16
00860013905958Integrity Orthopaedics9010019010012025-05-16
00860013905965Integrity Orthopaedics9020019020012025-05-16
00860013905972Integrity Orthopaedics9010059010052025-05-16
00860013905989Integrity Orthopaedics9010049010042025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903993303863AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: WhiteAuxein Medical Private LimitedMBI2026-04-30
08903993457009AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457368AUXILOCK® 2.8mm Titanium Screw-In Suture Anchor With One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457375AUXILOCK® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457467AUXILOCK® GFS Mini, Loop: 15mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-30
08903993457450AUXILOCK® GFS Mini, Loop: 12mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-18
08903993499887AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid:White/BlAuxein Medical Private LimitedMBI2026-04-18
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
07613327661989KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327661996KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662009KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662023KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
08437019739867WasherCap™ Fixation System 11mmABANZA TECNOMED SL.MBI2025-03-10
08437019739898WasherCap Mini Fixation system 3.5mmABANZA TECNOMED SL.MBI2025-02-25
08437019739904WasherCap Mini Fixation system 4.5mmABANZA TECNOMED SL.MBI2025-02-25
08800298539143GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539150GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539167GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539174GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539228GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539235GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
09348215029104Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029111Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029128Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26