Endo-Model Modular Knee Prosthesis System 15-2961/16

GUDID 04026575214082

Femoral Segment

WALDEMAR LINK GmbH & Co. KG

Knee arthroplasty wedge

• Primary Device ID: 04026575214082
• NIH Device Record Key: 8cc907b6-ae13-4b08-aa5f-b3243e110971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Model Modular Knee Prosthesis System
• Version Model Number: 15-2961/16
• Catalog Number: 15-2961/16
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575214082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211768

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-15
• Device Publish Date: 2021-10-07

On-Brand Devices [Endo-Model Modular Knee Prosthesis System]

• 04026575386512: Rotational Knee Joint Prosthesis,Femoral component, intracondylar
• 04026575386505: Rotational Knee Joint Prosthesis,Femoral component, intracondylar
• 04026575386499: Rotational Knee Joint Prosthesis,Femoral component, intracondylar
• 04026575386482: Rotational Knee Joint Prosthesis,Femoral component, intracondylar
• 04026575386475: Rotational Knee Joint Prosthesis,Femoral component, intracondylar
• 04026575386468: Rotational Knee Joint Prosthesis,Femoral component, intracondylar
• 04026575386406: Rotational Knee Joint Prosthesis,with anti-luxation device, intracondylar
• 04026575383276: Rotational Knee Joint Prosthesis,Femoral component, condylus replacement
• 04026575383252: Rotational Knee Joint Prosthesis,Femoral component, condylus replacement
• 04026575381760: Rotational Knee Joint Prosthesis,Femoral component, condylus replacement
• 04026575381753: Rotational Knee Joint Prosthesis,Femoral component, condylus replacement
• 04026575316717: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316700: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316694: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316687: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316670: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316663: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316656: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316649: Hinge Knee Joint Prosthesis,Femoral component
• 04026575316229: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316212: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316205: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316199: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316182: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316175: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316168: Rotational Knee Joint Prosthesis,Femoral component
• 04026575316120: Rotational Knee Joint Prosthesis,Femoral component
• 04026575383214: Rotational Knee Joint Prosthesis,Femoral component, condylus replacement
• 04026575383191: Rotational Knee Joint Prosthesis,Femoral component, condylus replacement
• 04026575431724: Modular Stem
• 04026575431717: Modular Stem
• 04026575431700: Modular Stem
• 04026575431694: Modular Stem
• 04026575431687: Modular Stem
• 04026575431670: Modular Stem
• 04026575431663: Modular Stem
• 04026575431656: Modular Stem
• 04026575431649: Modular Stem
• 04026575326037: Modular Stem,Cylindrical
• 04026575326020: Modular Stem,Cylindrical
• 04026575326013: Modular Stem,Cylindrical
• 04026575326006: Modular Stem,Cylindrical
• 04026575325993: Modular Stem,Cylindrical
• 04026575325986: Modular Stem,Cylindrical
• 04026575325979: Modular Stem,Cylindrical
• 04026575325962: Modular Stem,Cylindrical
• 04026575325955: Modular Stem,Cylindrical
• 04026575325948: Modular Stem,Cylindrical
• 04026575325931: Modular Stem,Cylindrical
• 04026575325924: Modular Stem,Cylindrical