FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867498976
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-5410T-AMGS-S
Catalog number
AR-5410T-AMGS-S
Device description
VIP™ Augmented MGS Reamer, Locking, S
Published
2025-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00888867498976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867498976008888674989768888674989760888867498976

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.

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
00888867417229Arthrex®AR-9096A-14-30LAR-9096A-14-30L2026-07-22
00888867417236Arthrex®AR-9096A-14-30RAR-9096A-14-30R2026-07-22
00888867417250Arthrex®AR-9096A-14-32LAR-9096A-14-32L2026-07-22
00888867417274Arthrex®AR-9096A-14-32RAR-9096A-14-32R2026-07-22
00888867417281Arthrex®AR-9096A-14-34LAR-9096A-14-34L2026-07-22
00888867417298Arthrex®AR-9096A-14-34RAR-9096A-14-34R2026-07-22
00888867417304Arthrex®AR-9096A-14-36LAR-9096A-14-36L2026-07-22
00888867417311Arthrex®AR-9096A-14-36RAR-9096A-14-36R2026-07-22
00888867417328Arthrex®AR-9096A-14-38LAR-9096A-14-38L2026-07-22
00888867417335Arthrex®AR-9096A-14-38RAR-9096A-14-38R2026-07-22
00888867417342Arthrex®AR-9096A-14-40LAR-9096A-14-40L2026-07-22
00888867417359Arthrex®AR-9096A-14-40RAR-9096A-14-40R2026-07-22
00888867417366Arthrex®AR-9096A-14-42LAR-9096A-14-42L2026-07-22
00888867417373Arthrex®AR-9096A-14-42RAR-9096A-14-42R2026-07-22
00888867417380Arthrex®AR-9096A-14-44LAR-9096A-14-44L2026-07-22
00888867417397Arthrex®AR-9096A-14-44RAR-9096A-14-44R2026-07-22
00888867417403Arthrex®AR-9096A-14-46LAR-9096A-14-46L2026-07-22
00888867417410Arthrex®AR-9096A-14-46RAR-9096A-14-46R2026-07-22
00888867280502Arthrex®ABS-4080DABS-4080D2018-06-22
00888867084032Arthrex®ABS-10067ABS-100672017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
05404028001288SurgiCase PlannerMaterialise NVPHX2026-07-16
05404028001288SurgiCase PlannerMaterialise NVQHE2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14