FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867315471
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5400-20
Catalog number
AR-5400-20
Device description
SIZE 20 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
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
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867315471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867315471008888673154718888673154710888867315471

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
00888867304598Arthrex®AR-7285AR-72852026-07-08
00888867304604Arthrex®AR-7286AR-72862026-07-08
00888867304789Arthrex®AR-7285-1AR-7285-12026-07-08
00888867304796Arthrex®AR-7286-1AR-7286-12026-07-08
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867097216Arthrex®AR-1938PHSAR-1938PHS2017-05-11
00888867157767Arthrex®AR-1588TN-2AR-1588TN-22017-08-15
00888867178649Arthrex®AR-8827L-32SAR-8827L-32S2017-04-07
00888867178694Arthrex®AR-8827L-42SAR-8827L-42S2017-04-07
00888867178731Arthrex®AR-8827L-50SAR-8827L-50S2017-04-07
00888867178748Arthrex®AR-8827L-52SAR-8827L-52S2017-04-07
00888867178755Arthrex®AR-8827L-54SAR-8827L-54S2017-05-11
00888867178762Arthrex®AR-8827L-56SAR-8827L-56S2017-05-11
00888867178779Arthrex®AR-8827L-58SAR-8827L-58S2017-05-11
00888867179455Arthrex®AR-8835-65SAR-8835-65S2017-04-07
00888867179462Arthrex®AR-8835-70SAR-8835-70S2017-04-07
00888867179479Arthrex®AR-8835-75SAR-8835-75S2017-04-07
00888867179486Arthrex®AR-8835-80SAR-8835-80S2017-04-07
00888867196537Arthrex®AR-8943C-07SAR-8943C-07S2017-05-11
00888867196582Arthrex®AR-8943C-12SAR-8943C-12S2017-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
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03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
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