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Biomet Knee System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
BIOMET KNEE SYSTEM FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Model / Reference
141216 FDA UDI

Identifiers

Catalog Number
141216 FDA UDI
Primary DI / UDI-DI
00880304005303 FDA UDI
510(k) Number
K010212 FDA UDI
K142933 FDA UDI
K171054 FDA UDI
K915132 FDA UDI
FDA Product Code
MBH FDA UDI
MBV FDA UDI
JWH FDA UDI
HRY FDA UDI
OIY FDA UDI
GMDN Term
Uncoated knee tibia prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3565 FDA UDI
888.3560 FDA UDI
888.3530 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: Uncoated knee tibia prosthesis, metallic

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

Similar devices

Also classified as Uncoated knee tibia prosthesis, metallic.

Cleared under the same submission

K010212 also covers:

K142933 also covers:

K171054 also covers:

K915132 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 3ecdb48c-3f92-41bc-bbc1-f1ecdf29c5d2 36 fields · synced May 30, 2026