FDA.reportPublic FDA data

LINK Instruments - Trial implants and size gauges

Primary DI
04026575209675
Brand
LINK Instruments - Trial implants and size gauges
Company
WALDEMAR LINK GmbH & Co. KG
Model
15-2535/16
Device description
Knee tibia prosthesis trial, reusable - Endo Model Knee System
Published
2022-12-20
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
JDTCAP, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDTCap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575209675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575209675040265752096754026575209675

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
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
00840124516427FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
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00840124516441FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516458FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516465FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124516472FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124521070FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124521094FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124521254FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-09
00840124517431FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517448FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517455FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517462FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517479FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124517486FibFixFUSION ORTHOPEDICS, LLCJDT2026-04-08
00840124521285Metalogix RevolutionFUSION ORTHOPEDICS, LLCJDT2025-07-23
04026575209644LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20
04026575209651LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20
04026575209668LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KGJDT2022-12-20