FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867264953
Brand
Arthrex®
Company
ARTHREX, INC.
Model
5566VIP
Catalog number
5566VIP
Device description
ArthrexVIP Web Portal
Published
2024-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QHEShoulder arthroplasty implantation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867264953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867264953008888672649538888672649530888867264953

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1

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

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Primary DIBrandCompanyProduct codePublished
05404028001288SurgiCase PlannerMaterialise NVQHE2026-07-16
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05404028001110SurgiCase Planner Materialise NVQHE2025-12-17
05404028001028SurgiCase Planner Materialise NVQHE2025-08-28
03700434023831BlueprintTORNIERQHE2025-06-17
03700434023848BlueprintTORNIERQHE2025-06-17
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00810022403181CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403198CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403204CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00888867498952Arthrex®ARTHREX, INC.QHE2025-05-01
00888867498969Arthrex®ARTHREX, INC.QHE2025-05-01
00888867498976Arthrex®ARTHREX, INC.QHE2025-05-01
07630542730153MyShoulder PlannerMedacta International SAQHE2025-02-06
05420060366116Match Point SystemMaterialise NVQHE2024-12-09
05420060366123Match Point SystemMaterialise NVQHE2024-12-09
05420060367120AtlasPlanMaterialise NVQHE2024-07-19
03700434023695Shoulder iDTORNIERQHE2024-05-23
03700434023701Shoulder iDTORNIERQHE2024-05-23
03700434023718Shoulder iDTORNIERQHE2024-05-23
03700434023725Shoulder iDTORNIERQHE2024-05-23