FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867315419
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5400-14
Catalog number
AR-5400-14
Device description
SIZE 14 LEG, GLENOID TARGETER
Published
2020-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867315419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867315419008888673154198888673154190888867315419

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706828Mini Baseplate Sizer Cannulated HandleBiomet Orthopedics, LLCKWS2026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleBiomet Orthopedics, LLCKWS2026-03-19
10885862648549EquinoxeExactech, Inc.KWS2026-03-19
10885862648556EquinoxeExactech, Inc.KWS2026-03-19
10885862648563EquinoxeExactech, Inc.KWS2026-03-19
10885862656582EquinoxeExactech, Inc.KWS2026-02-09
00840338607669Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607713Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607720Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612342Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612366Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612373Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612380Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00889024692794Augmented BP Reamer Guide ExtractorBiomet Orthopedics, LLCKWS2025-12-18
00889024703742Versa-Dial® Shoulder SystemBiomet Orthopedics, LLCKWS2025-12-09
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.KWS2025-11-17
00889024691476Identity HumeralZimmer, Inc.KWS2025-09-22
00889024691445Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691490Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691599Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691605Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691612Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691629Identity HumeralZimmer, Inc.KWS2025-09-17
10885862657527EquinoxeExactech, Inc.KWS2025-09-09
10885862657534EquinoxeExactech, Inc.KWS2025-09-09
10885862657541EquinoxeExactech, Inc.KWS2025-09-09
10885862657558EquinoxeExactech, Inc.KWS2025-09-09
10885862657572EquinoxeExactech, Inc.KWS2025-09-09
10885862657602EquinoxeExactech, Inc.KWS2025-09-09
10885862657626EquinoxeExactech, Inc.KWS2025-09-09