FDA.reportPublic FDA data

LINK Instruments - Trial implants and size gauges

Primary DI
04026575398201
Brand
LINK Instruments - Trial implants and size gauges
Company
WALDEMAR LINK GmbH & Co. KG
Model
340-011
Device description
Patella prosthesis trial - General Instrument
Published
2022-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04026575398201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575398201040265753982014026575398201

GMDN Terms#

Term, Definition table
TermDefinition
Patella prosthesis trialA copy of a final patella 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, and to check that patellar ligament balancing is correct. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
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
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
08806373887741BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887758BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
08806373887765BENCOX Surgical InstrumentsCorentec Co., LtdHWT2026-01-12
09348215164577Longboard Trial Neck LOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164584Longboard Trial Neck SOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
09348215164591Longboard Trial Neck HOSIGNATURE ORTHOPAEDICS PTY LTDHWT2025-10-10
G791EFTEMPS080WishFIXRed Star Contract Manufacturing Inc.HWT2025-10-06
07613327524536INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524543INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327524550INSTRUMENTHowmedica Osteonics Corp.HWT2024-02-22
07613327548716InstrumentHowmedica Osteonics Corp.HWT2024-02-22
07613327565850INSTRUMENTHowmedica Osteonics Corp.HWT2024-01-08
09348215082017Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082024Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082031Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082048Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215082055Dual Mobility Logical Insert TrialSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215084998Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085001Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085018Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085025Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085032Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085049Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085056Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085063Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085070Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085087Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085094Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085100Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20
09348215085117Dual Mobility Trial Head SleeveSIGNATURE ORTHOPAEDICS PTY LTDHWT2023-01-20