FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867347939
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-611-37
Catalog number
AR-611-37
Device description
iBal UKA, Tibial D-Ring Trial, Size 4
Published
2020-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867347939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867347939008888673479398888673479390888867347939

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
131747628
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867050372Arthrex®AR-8934BNFAR-8934BNF2018-12-13
00888867290778Arthrex®AR-1938PSSAR-1938PSS2018-04-19
00888867348691Arthrex®AR-1934BCT-2AR-1934BCT-22022-07-11
00888867375116Arthrex®AR-8934BCSTAR-8934BCST2021-05-24
00888867375123Arthrex®AR-8934BCST-2AR-8934BCST-22021-05-24
00888867443624Arthrex®AR-2424PHSAR-2424PHS2024-01-25
00888867443631Arthrex®AR-2424PHS-1AR-2424PHS-12024-01-25
00888867384811Arthrex®AR-8934BCST-1AR-8934BCST-12021-05-24
00888867384828Arthrex®AR-8934BCST-2-1AR-8934BCST-2-12021-05-24
00888867285057Arthrex®AR-1934PF-24-1AR-1934PF-24-12020-12-15
00888867293830Arthrex®AR-1938PSS-1AR-1938PSS-12018-10-29
00888867335035Arthrex®AR-2923BCSAR-2923BCS2020-03-16
00888867088306Arthrex®AR-13110R-02AR-13110R-022017-02-15
00888867046641Arthrex®AR-8825BAR-8825B2017-02-15
00888867046672Arthrex®AR-8825PAR-8825P2017-02-15
00888867131491Arthrex®AR-8923BCAR-8923BC2017-02-15
00888867022874Arthrex®AR-1922BCAR-1922BC2017-02-15
00888867022959Arthrex®AR-1922PSAR-1922PS2017-02-15
00888867023017Arthrex®AR-1923BCAR-1923BC2017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295553588ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553595ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553601ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553618ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10705034579900N/AMedos International SàrlHWT2026-08-26
10705034579917N/AMedos International SàrlHWT2026-08-26
10705034579924N/AMedos International SàrlHWT2026-08-26
00889024711464Comp Mini Humeral Tray Trial Stem AdapterZimmer, Inc.HWT2026-08-25
00889024713277Universal Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713284Right Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713291Left Uni Knee TensorZimmer, Inc.HWT2026-08-25
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
00885556841532XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841549XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841556XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841563XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841570XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841587XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841594XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841600XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841655XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841662XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841679XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841686XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841693XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841709XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841716XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841723XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841730XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02