Unicondylar Sled Prosthesis 15-2220/46

GUDID 04026575429080

Femoral Component

WALDEMAR LINK GmbH & Co. KG

Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis Coated unicondylar knee femur prosthesis

• Primary Device ID: 04026575429080
• NIH Device Record Key: 40054802-2051-48de-a30b-95fe53be2066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unicondylar Sled Prosthesis
• Version Model Number: 15-2220/46
• Catalog Number: 15-2220/46
• 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: true
• 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	04026575429080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152431

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-09-27
• Device Publish Date: 2016-05-26

On-Brand Devices [Unicondylar Sled Prosthesis]

• 04026575436750: Tibial Component Metal-Backed PE-PorEx
• 04026575436743: Tibial Component Metal-Backed PE-PorEx
• 04026575436736: Tibial Component Metal-Backed PE-PorEx
• 04026575429226: Tibial Component Metal-Backed PE-PorEx
• 04026575429219: Tibial Component Metal-Backed PE-PorEx
• 04026575429202: Tibial Component Metal-Backed PE-PorEx
• 04026575429189: Tibial Component Metal-Backed PE-PorEx
• 04026575429172: Tibial Component Metal-Backed PE-PorEx
• 04026575429165: Tibial Component Metal-Backed PE-PorEx
• 04026575429141: Tibial Component Metal-Backed PE-PorEx
• 04026575429134: Tibial Component Metal-Backed PE-PorEx
• 04026575429127: Tibial Component Metal-Backed PE-PorEx
• 04026575429103: Femoral Component
• 04026575429097: Femoral Component
• 04026575429080: Femoral Component
• 04026575429073: Femoral Component
• 04026575436729: Tibia Plateau,metal-backed
• 04026575436712: Tibia Plateau,metal-backed
• 04026575436705: Tibia Plateau,metal-backed
• 04026575359486: Tibia Plateau,all-polyethylene
• 04026575359479: Tibia Plateau,all-polyethylene
• 04026575359462: Tibia Plateau,all-polyethylene
• 04026575359455: Tibia Plateau,all-polyethylene
• 04026575209491: Femoral Component
• 04026575044160: Tibia Plateau,metal-backed
• 04026575044153: Tibia Plateau,metal-backed
• 04026575044146: Tibia Plateau,metal-backed
• 04026575044122: Tibia Plateau,metal-backed
• 04026575044115: Tibia Plateau,metal-backed
• 04026575044108: Tibia Plateau,metal-backed
• 04026575044085: Tibia Plateau,metal-backed
• 04026575044078: Tibia Plateau,metal-backed
• 04026575044061: Tibia Plateau,metal-backed
• 04026575044047: Tibia Plateau,all-polyethylene
• 04026575044030: Tibia Plateau,all-polyethylene
• 04026575044023: Tibia Plateau,all-polyethylene
• 04026575044016: Tibia Plateau,all-polyethylene
• 04026575044009: Tibia Plateau,all-polyethylene
• 04026575043996: Tibia Plateau,all-polyethylene
• 04026575043989: Tibia Plateau,all-polyethylene
• 04026575043972: Tibia Plateau,all-polyethylene
• 04026575043965: Tibia Plateau,all-polyethylene
• 04026575043958: Tibia Plateau,all-polyethylene
• 04026575043941: Tibia Plateau,all-polyethylene
• 04026575043934: Tibia Plateau,all-polyethylene
• 04026575043910: Femoral Component
• 04026575043903: Femoral Component
• 04026575043897: Femoral Component