FDA.reportPublic FDA data

LinkSymphoKnee

Primary DI
04026575533367
Brand
LinkSymphoKnee
Company
WALDEMAR LINK GmbH & Co. KG
Model
880-299/14
Device description
Articulating surface, vitamin E highly crosslinked UHMWPE, fixed bearing UC
Published
2023-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230471000LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG2023-03-21JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575533367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575533367040265755333674026575533367

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia stem prosthesisAn implantable uncoated shaft-like device intended to be attached to the tibial baseplate of a modular knee tibia prosthesis to provide anchorage within the tibia. It has a threaded proximal end and is shaped to provide a tight fit with the internal tibial cortex; it is made of metallic materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575083237Endo-Model Knee System - EVO Knee System - OptiStem Instr151-16/16151-16/162026-05-15
04026575083282Endo-Model Knee System - EVO Knee System - OptiStem Instr151-17/17151-17/172026-05-15
04026575083329Endo-Model Knee System - EVO Knee System - OptiStem Instr151-18/18151-18/182026-05-15
04026575083404Endo-Model Knee System - EVO Knee System - OptiStem Instr151-19/19151-19/192026-05-15
04026575083503Endo-Model Knee System - EVO Knee System - OptiStem Instr151-20/20151-20/202026-05-15
04026575083640Endo-Model Knee System - EVO Knee System - OptiStem Instr151-21/21151-21/212026-05-15
04026575083732Endo-Model Knee System - EVO Knee System - OptiStem Instr151-04/04151-04/042026-05-15
04026575092307LinkSymphoKnee - Instruments151-09/09151-09/092026-05-15
04026575092321LinkSymphoKnee - Instruments151-10/10151-10/102026-05-15
04026575092345LinkSymphoKnee - Instruments151-11/11151-11/112026-05-15
04026575092352Endo-Model Knee System - EVO Knee System - OptiStem Instr151-12/12151-12/122026-05-15
04026575092437Endo-Model Knee System - EVO Knee System - OptiStem Instr151-13/13151-13/132026-05-15
04026575093014Endo-Model Knee System - EVO Knee System - OptiStem Instr151-14/14151-14/142026-05-15
04026575093021Endo-Model Knee System - EVO Knee System - OptiStem Instr151-15/15151-15/152026-05-15
04026575048168General Instrument15-80352026-02-02
04026575080106MP Reconstruction System Instruments134-011/002026-02-02
04026575080175MP Reconstruction System Instruments134-031/002026-02-02
04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000115INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000122INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000146INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
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07613327000337INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
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07613327000467INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000597INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010107INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010114INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010121INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327013511TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013528TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013542TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013559TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013573TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327014488ScorpioHowmedica Osteonics Corp.JWH2015-09-24