WaveKahuna™ PWL2-1155-A

GUDID M528PWL21155A0

Femoral Component, Left, 11.5 mm Offset, Kahuna

ARTHROSURFACE INCORPORATED

Partial-resurfacing knee femur prosthesis
Primary Device IDM528PWL21155A0
NIH Device Record Keyc1b9beea-3d21-4ceb-bafe-929b41017023
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaveKahuna™
Version Model NumberPWL2-1155-A
Catalog NumberPWL2-1155-A
Company DUNS144666109
Company NameARTHROSURFACE INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-520-3003
Emailcontact@arthrosurface.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM528PWL21155A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-20
Device Publish Date2020-03-12

On-Brand Devices [WaveKahuna™]

M528PWR21155W0Femoral Component, Right, 11.5mm Offset, Kahuna, CE
M528PWR21155A0Femoral Component, Right, 11.5 mm Offset, Kahuna
M528PWR21005W0Femoral Component, Right, 10.0mm Offset, Kahuna, CE
M528PWR21005A0Femoral Component, Right, 10.0 mm Offset, Kahuna
M528PWR20855W0Femoral Component, Right, 8.5mm Offset, Kahuna, CE
M528PWR20855A0Femoral Component, Right, 8.5 mm Offset, Kahuna
M528PWR20705W0Femoral Component, Right, 7.0mm Offset, Kahuna,CE
M528PWR20705A0Femoral Component, Right, 7.0 mm Offset, Kahuna
M528PWL21155W0Femoral Component, Left, 11.5 mm Offset, Kahuna, CE
M528PWL21155A0Femoral Component, Left, 11.5 mm Offset, Kahuna
M528PWL21005W0Femoral Component, Left, 10.0mm Offset, Kahuna, CE
M528PWL21005A0Femoral Component, Left, 10.0 mm Offset, Kahuna
M528PWL20855W0Femoral Component, Left, 8.5mm Offset, Kahuna, CE
M528PWL20855A0Femoral Component, Left, 8.5 mm Offset, Kahuna
M528PWL20705W0Femoral Component, Left, 7.0mm Offset, Kahuna, CE
M528PWL20705A0Femoral Component, Left, 7.0 mm Offset, Kahuna

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