FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867300927
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8719MX-1515
Catalog number
AR-8719MX-1515
Device description
SuperMX Compression Staple, 15W x 15L
Published
2019-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867300927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867300927008888673009278888673009270888867300927

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867543904Arthrex®AR-1101TH-13CT-SAR-1101TH-13CT-S2026-09-25
00888867543911Arthrex®AR-1101TH-8CT-SAR-1101TH-8CT-S2026-09-25
00888867543928Arthrex®AR-1101TH-13OT-SAR-1101TH-13OT-S2026-09-25
00888867543935Arthrex®AR-1101TH-8OT-SAR-1101TH-8OT-S2026-09-25
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867291690Arthrex®AR-3350-4031AR-3350-40312018-12-13
00888867291751Arthrex®AR-3355-4031AR-3355-40312018-12-13
00888867161085Arthrex®AR-3350-4071AR-3350-40712018-12-13
00888867161207Arthrex®AR-3355-4071AR-3355-40712018-12-13
00888867504059Arthrex®AR-9650CAR-9650C2026-09-21
00888867504066Arthrex®AR-9650C-01AR-9650C-012026-09-21
00888867504073Arthrex®AR-9650C-02AR-9650C-022026-09-21
00888867570764Arthrex®AR-9650SFL-10256AR-9650SFL-102562026-09-21
00888867570771Arthrex®AR-9650SFL-11250AR-9650SFL-112502026-09-21
00888867550292Arthrex®AR-6533S-STAR-6533S-ST2026-09-18
00888867550308Arthrex®AR-6533S-XLAR-6533S-XL2026-09-18
00888867550315Arthrex®AR-6534S-STAR-6534S-ST2026-09-18
00888867550322Arthrex®AR-6534S-XLAR-6534S-XL2026-09-18
00888867550339Arthrex®AR-6533S-STSAR-6533S-STS2026-09-18
00888867550346Arthrex®AR-6533S-XLSAR-6533S-XLS2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867574342Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574359Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574366Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574373Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574380Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574397Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574403Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574410Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574427Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574434Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574441Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574458Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574465Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574595Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574601Arthrex®ARTHREX, INC.JDR2026-09-18
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00810135964180VertexNVision Biomedical Technologies, Inc.JDR2025-12-17
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
07630037889397APTUSMedartis AGJDR2023-03-03
00810005661010VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661027VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661034VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661041VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661058VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661065VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661072VertexNVision Biomedical Technologies, Inc.JDR2020-12-28