FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867232273
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-523-B211
Catalog number
AR-523-B211
Device description
PS TIBIAL BEARING, SIZE 2, 11MM, VIT E
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
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867232273PrimaryGS10
M150AR523B2111SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867232273008888672322738888672322730888867232273

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia/insert prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision). It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it includes a polyethylene (PE) insert/platform for femoral articulation. Device implantation is intended to be performed with bone cement.

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
00888867620964Arthrex®AR-3210-0067AR-3210-00672026-10-12
00888867620971Arthrex®AR-3210-0067-PKAR-3210-0067-PK2026-10-12
00888867620988Arthrex®AR-3210-0068AR-3210-00682026-10-12
00888867620995Arthrex®AR-3210-0068-PKAR-3210-0068-PK2026-10-12
00888867520745Arthrex®AR-1360FT-KFTAR-1360FT-KFT2026-01-21
00888867429857Arthrex®AR-2600FSB-1AR-2600FSB-12023-05-24
00888867429864Arthrex®AR-2600FSB-2AR-2600FSB-22023-05-24
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867354067Arthrex®AR-1360FT-BCAR-1360FT-BC2020-12-15
00888867101951Arthrex®AR-3600DCAR-3600DC2018-12-21
00888867096066Arthrex®AR-1677BC-CPAR-1677BC-CP2017-02-15
00888867084384Arthrex®ABS-3005ABS-30052017-02-15
00888867084407Arthrex®ABS-3008ABS-30082017-02-15
00888867084421Arthrex®ABS-3016ABS-30162017-02-15
00888867084148Arthrex®ABS-2001-01ABS-2001-012017-02-15
00888867084155Arthrex®ABS-2001-02ABS-2001-022017-02-15
00888867084162Arthrex®ABS-2001-05ABS-2001-052017-02-15
00888867084179Arthrex®ABS-2001-10ABS-2001-102017-02-15
00888867084186Arthrex®ABS-2002-01ABS-2002-012017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
E31442411410SignatureMaterialise NVMBH2026-09-24
E31442422415SignatureMaterialise NVMBH2026-09-24
E31442422450SignatureMaterialise NVMBH2026-09-24
E31442422451SignatureMaterialise NVMBH2026-09-24
E31442422452SignatureMaterialise NVMBH2026-09-24
E31442422453SignatureMaterialise NVMBH2026-09-24
E31442422455SignatureMaterialise NVMBH2026-09-24
E31442422456SignatureMaterialise NVMBH2026-09-24
E31442422457SignatureMaterialise NVMBH2026-09-24
E31442422458SignatureMaterialise NVMBH2026-09-24
E31442422460SignatureMaterialise NVMBH2026-09-24
E31442422461SignatureMaterialise NVMBH2026-09-24
E31442422462SignatureMaterialise NVMBH2026-09-24
E31442422463SignatureMaterialise NVMBH2026-09-24
E31442422465SignatureMaterialise NVMBH2026-09-24
E31442422466SignatureMaterialise NVMBH2026-09-24
E31442422467SignatureMaterialise NVMBH2026-09-24
E31442422468SignatureMaterialise NVMBH2026-09-24
E31442422470SignatureMaterialise NVMBH2026-09-24
E31442422471SignatureMaterialise NVMBH2026-09-24
E31442422472SignatureMaterialise NVMBH2026-09-24
E31442422473SignatureMaterialise NVMBH2026-09-24