FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867057289
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9104-01
Catalog number
AR-9104-01
Device description
GLENOID, POLY WITH KEEL, SMALL
Published
2017-02-15
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010124000ARTHREX UNIVERS 30 SHOULDER PROSTHESISArthrex, Inc.2001-04-06KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867057289PrimaryGS10
M150AR9104012SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867057289008888670572898888670572890888867057289

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis, prefabricatedAn implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

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
00888867576032Arthrex®AR-3636-REMPAR-3636-REMP2026-10-20
00888867576056Arthrex®AR-3641SP-REMPAR-3641SP-REMP2026-10-20
00888867576070Arthrex®AR-6573-1AR-6573-12026-10-20
00888867576087Arthrex®AR-6573-2AR-6573-22026-10-20
00888867568280Arthrex®AR-3210-0050-SJAR-3210-0050-SJ2026-10-16
00888867568297Arthrex®AR-3210-0051-SJAR-3210-0051-SJ2026-10-16
00888867568303Arthrex®AR-3210-0059-PKAR-3210-0059-PK2026-10-16
00888867568310Arthrex®AR-3210-0063-PKAR-3210-0063-PK2026-10-16
00888867568457Arthrex®AR-8650DS-NAR-8650DS-N2026-10-16
00888867427143Arthrex®AR-S6524-025-230CAR-S6524-025-230C2023-06-05
00888867389533Arthrex®AR-9928BCK-MISAR-9928BCK-MIS2023-05-22
00888867276086Arthrex®AR-9437-16AR-9437-162022-07-15
00888867060401Arthrex®AR-9439-16AR-9439-162018-06-02
00888867060418Arthrex®AR-9439-18AR-9439-182018-06-02
00888867060425Arthrex®AR-9441-16AR-9441-162018-06-14
00888867060432Arthrex®AR-9441-18AR-9441-182018-06-02
00888867060449Arthrex®AR-9443-16AR-9443-162018-06-14
00888867060456Arthrex®AR-9443-18AR-9443-182018-06-14
00888867060463Arthrex®AR-9445-17AR-9445-172018-06-28
00888867060470Arthrex®AR-9445-19AR-9445-192018-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncHSD2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08