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WaveKahuna™

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name
WaveKahuna™ FDA UDI
Generic Name
Partial-resurfacing knee femur prosthesis FDA UDI
Device Name
Femoral Component, Right, 8.5 mm Offset, Kahuna FDA UDI
Model / Reference
PWR2-0855-A FDA UDI
Description
Femoral Component, Right, 8.5 mm Offset, Kahuna FDA UDI

Identifiers

Catalog Number
PWR2-0855-A FDA UDI
Primary DI / UDI-DI
M528PWR20855A0 FDA UDI
510(k) Number
K181280 FDA UDI
FDA Product Code
KRR FDA UDI
GMDN Term
Partial-resurfacing knee femur prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Partial-resurfacing knee femur prosthesis

WaveKahuna™ by Arthrosurface Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partial-resurfacing knee femur prosthesis.

Cleared under the same submission

K181280 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrosurface Incorporated

Sources (1)

  • FDA UDI 640b132d-54de-43d7-b0c8-a3d4520189f4 36 fields · synced May 30, 2026