FDA.reportPublic FDA data

LINK Instruments - Fixation instruments

Primary DI
04026575397617
Brand
LINK Instruments - Fixation instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
16-3279/00
Device description
Orthopaedic prosthesis implantation instrument, reusable - Megasystem-C Tumor- and Revision System
Published
2022-12-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575397617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575397617040265753976174026575397617

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849771050374NAKEY SURGICAL, INC.GDJ2023-03-31
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G25003048110Backhaus Towel Forceps 11cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048130Backhaus Towel Forceps 13cmN S SURGICAL COMPANYGDJ2023-01-31
10849771050381NAKEY SURGICAL, INC.GDJ2023-01-26
10849771050398NAKEY SURGICAL, INC.GDJ2023-01-26
14026704789570PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789662PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
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14026704791160PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791177PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791184PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791191PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791276PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791283PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791290PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791306PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791566PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791573PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791634PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
10886982311146NASynthes GmbHGDJ2022-11-29
10886982311153NASynthes GmbHGDJ2022-11-29
10886982311160NASynthes GmbHGDJ2022-11-29
10886982311177NASynthes GmbHGDJ2022-11-29
ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15
ESOT002462NAS & T AGGDJ2022-09-15
ESOT002862NAS & T AGGDJ2022-09-15
ESOT002871NAS & T AGGDJ2022-09-15