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
00888867007482Arthrex®AR-13100-05.0SAR-13100-05.0S2017-01-20
00888867007529Arthrex®AR-13100-09.0SAR-13100-09.0S2017-01-20
00888867007567Arthrex®AR-13100-11.0SAR-13100-11.0S2017-01-20
00888867007604Arthrex®AR-13100-15.0SAR-13100-15.0S2017-01-20
00888867007628Arthrex®AR-13100-17.5SAR-13100-17.5S2017-01-20
00888867008564Arthrex®AR-13200-03.0SAR-13200-03.0S2017-01-20
00888867204041Arthrex®AR-8952XLSAR-8952XLS2017-07-18
00888867210424Arthrex®AR-8933L-26SAR-8933L-26S2017-08-31
00888867210431Arthrex®AR-8933L-28SAR-8933L-28S2017-08-31
00888867210448Arthrex®AR-8933L-30SAR-8933L-30S2017-08-31
00888867210462Arthrex®AR-8933L-34SAR-8933L-34S2017-08-31
00888867210479Arthrex®AR-8933L-36SAR-8933L-36S2017-08-31
00888867210493Arthrex®AR-8933L-40SAR-8933L-40S2017-08-31
00888867251960Arthrex®AR-8958-01SAR-8958-01S2017-11-28
00888867266872Arthrex®AR-8952PPLAR-8952PPL2017-03-28
00888867266896Arthrex®AR-8952PSRAR-8952PSR2017-03-28
00888867266957Arthrex®AR-8952PPRAR-8952PPR2017-03-28
00888867371828Arthrex®AR-8924SAR-8924S2023-05-25
00888867251939Arthrex®AR-8958-02AR-8958-022017-02-15
00888867279285Arthrex®AR-7249-12-1AR-7249-12-12017-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001110SurgiCase Planner Materialise NVQHE2025-12-17
05404028001028SurgiCase Planner Materialise NVQHE2025-08-28
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00810022403051CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403068CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403099CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403105CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403129CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403136CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403143CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403150CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403167CORE Shoulder SystemLink Bio CorpQHE2025-06-04
00810022403174CORE Shoulder SystemLink Bio CorpQHE2025-06-04
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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
03700434023732Shoulder iDTORNIERQHE2024-05-23
03700434023107BlueprintTORNIERQHE2024-03-14