WaveKahuna™ PWL2-0855-W

GUDID M528PWL20855W0

Femoral Component, Left, 8.5mm Offset, Kahuna, CE

ARTHROSURFACE INCORPORATED

Partial-resurfacing knee femur prosthesis

• Primary Device ID: M528PWL20855W0
• NIH Device Record Key: 3c3212dd-d6c2-4314-8d8c-ae15511be1f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveKahuna™
• Version Model Number: PWL2-0855-W
• Catalog Number: PWL2-0855-W
• Company DUNS: 144666109
• Company Name: ARTHROSURFACE INCORPORATED
• Device Count: 1
• DM Exempt: false
• 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

Customer Support Contacts

• Phone: 508-5203003
• Email: contact@arthrosurface.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M528PWL20855W0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181280

FDA Product Code

• KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

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: 2020-03-20
• Device Publish Date: 2020-03-12

On-Brand Devices [WaveKahuna™]

• M528PWR21155W0: Femoral Component, Right, 11.5mm Offset, Kahuna, CE
• M528PWR21155A0: Femoral Component, Right, 11.5 mm Offset, Kahuna
• M528PWR21005W0: Femoral Component, Right, 10.0mm Offset, Kahuna, CE
• M528PWR21005A0: Femoral Component, Right, 10.0 mm Offset, Kahuna
• M528PWR20855W0: Femoral Component, Right, 8.5mm Offset, Kahuna, CE
• M528PWR20855A0: Femoral Component, Right, 8.5 mm Offset, Kahuna
• M528PWR20705W0: Femoral Component, Right, 7.0mm Offset, Kahuna,CE
• M528PWR20705A0: Femoral Component, Right, 7.0 mm Offset, Kahuna
• M528PWL21155W0: Femoral Component, Left, 11.5 mm Offset, Kahuna, CE
• M528PWL21155A0: Femoral Component, Left, 11.5 mm Offset, Kahuna
• M528PWL21005W0: Femoral Component, Left, 10.0mm Offset, Kahuna, CE
• M528PWL21005A0: Femoral Component, Left, 10.0 mm Offset, Kahuna
• M528PWL20855W0: Femoral Component, Left, 8.5mm Offset, Kahuna, CE
• M528PWL20855A0: Femoral Component, Left, 8.5 mm Offset, Kahuna
• M528PWL20705W0: Femoral Component, Left, 7.0mm Offset, Kahuna, CE
• M528PWL20705A0: Femoral Component, Left, 7.0 mm Offset, Kahuna