Unicondylar Sled Prosthesis 15-2230/03

GUDID 04026575429134

Tibial Component Metal-Backed PE-PorEx

WALDEMAR LINK GmbH & Co. KG

Coated unicondylar knee tibia prosthesis

• Primary Device ID: 04026575429134
• NIH Device Record Key: 083ccb7c-eba6-4429-9e25-7f8e50fa5548
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unicondylar Sled Prosthesis
• Version Model Number: 15-2230/03
• Catalog Number: 15-2230/03
• 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: false
• Serial Number: true
• 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	04026575429134 [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