FDA.reportPublic FDA data

Endo-Model SL Knee Prosthesis System

Primary DI
04026575383382
Brand
Endo-Model SL Knee Prosthesis System
Company
WALDEMAR LINK GmbH & Co. KG
Model
16-2849/27
Catalog number
16-2849/27
Device description
Proximal Tibial Replacement Components,modular, neutral
Published
2015-11-01
Public version status
Update
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
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151008000LINK® MEGASYSTEM-C®Waldemar Link GmbH & Co. KG2015-08-26KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575383382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575383382040265753833824026575383382

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia/insert prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision). It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it includes a polyethylene (PE) insert/platform for femoral articulation. Device implantation is intended to be performed with bone cement.

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Lot or batch
true
Expiration 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
07611996074901SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074901SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LZO2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.JDI2016-08-19