FDA.reportPublic FDA data

Integrity Orthopaedics

Primary DI
00860013905972
Brand
Integrity Orthopaedics
Company
Integrity Orthopaedics, Inc
Model
901005
Catalog number
901005
Device description
Tendon Seam™ Instrument Kit - 4 Anchor
Published
2025-05-16
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
LXHOrthopedic Manual Surgical Instrument
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013905972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013905972008600139059728600139059720860013905972

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, single-useA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118804591
Device count
1
Kit
true
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
00860009782204Integrity Orthopaedics9010019010012023-02-13
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
00860013905989Integrity Orthopaedics9010049010042025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23