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Maxim Knee System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
MAXIM KNEE SYSTEM FDA UDI
Generic Name
Femur/tibia shaft prosthesis FDA UDI
Model / Reference
CP110646 FDA UDI

Identifiers

Catalog Number
CP110646 FDA UDI
Primary DI / UDI-DI
00880304025127 FDA UDI
510(k) Number
K033871 FDA UDI
FDA Product Code
JWH FDA UDI
JDI FDA UDI
KRO FDA UDI
GMDN Term
Femur/tibia shaft prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3350 FDA UDI
888.3510 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

No

FDA UDI

Category: Femur/tibia shaft prosthesis

Maxim Knee System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femur/tibia shaft prosthesis.

Cleared under the same submission

K033871 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI 39e9aba5-2b91-4c24-b053-fac25afcb4a0 36 fields · synced Jun 6, 2026