FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867315433
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5400-16
Catalog number
AR-5400-16
Device description
SIZE 16 LEG, GLENOID TARGETER
Published
2020-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
LLZSystem, image processing, radiological
PHWCold pack and vibrating massager
PHXshoulder prosthesis, reverse configuration
QHEShoulder arthroplasty implantation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
LLZSystem, Image Processing, RadiologicalRadiology2
PHWCold Pack And Vibrating MassagerPhysical Medicine1
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867315433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867315433008888673154338888673154330888867315433

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867430662Arthrex®AR-S7110-020U-330WAR-S7110-020U-330W2023-09-15
00888867427310Arthrex®AR-S7111-025-330WAR-S7111-025-330W2023-06-05
00888867427327Arthrex®AR-S7111-035-330WAR-S7111-035-330W2023-06-05
00888867427334Arthrex®AR-S7115-025-260WAR-S7115-025-260W2023-06-05
00888867427341Arthrex®AR-S7116-020-260WAR-S7116-020-260W2023-06-05
00888867427358Arthrex®AR-S7116-025U-330WAR-S7116-025U-330W2023-06-05
00888867427365Arthrex®AR-S7121-020-330WAR-S7121-020-330W2023-06-05
00888867427372Arthrex®AR-S7115-025-330WAR-S7115-025-330W2023-06-05
00888867427389Arthrex®AR-S7116-025-330WAR-S7116-025-330W2023-06-05
00888867427396Arthrex®AR-S7116-025-260WAR-S7116-025-260W2023-06-05
00888867427495Arthrex®AR-S7120-025-330WAR-S7120-025-330W2023-06-05
00888867427518Arthrex®AR-S7110-025-330WAR-S7110-025-330W2023-06-05
00888867427532Arthrex®AR-S7110-040-330WAR-S7110-040-330W2023-06-05
00888867427549Arthrex®AR-S7110-025-260WAR-S7110-025-260W2023-06-05
00888867427556Arthrex®AR-S7110-035-260WAR-S7110-035-260W2023-06-05
00888867427563Arthrex®AR-S7110-040-260WAR-S7110-040-260W2023-06-05
00888867427570Arthrex®AR-S7110-030-330WAR-S7110-030-330W2023-06-05
00888867427891Arthrex®AR-S7116-040-260WAR-S7116-040-260W2023-06-05
00888867427907Arthrex®AR-S7116-035U-260WAR-S7116-035U-260W2023-06-05
00888867430686Arthrex®AR-S7110-025U-330WAR-S7110-025U-330W2023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977644TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977651TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977668TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEKWS2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEPHX2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.QHE2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17