← Back to catalogue

Freedom

FDA UDI

Class II (US FDA UDI)

by Maxx Orthopedics Inc.

Identity

Trade Name
Freedom FDA UDI
Generic Name
Uncoated knee femur prosthesis, metallic FDA UDI
Device Name
Unicondylar Tibial Baseplate Size 5, Right Medial/Left Lateral FDA UDI
Model / Reference
BTRMLL500-UK FDA UDI
Description
Unicondylar Tibial Baseplate Size 5, Right Medial/Left Lateral FDA UDI

Identifiers

Primary DI / UDI-DI
00810008128152 FDA UDI
510(k) Number
K212870 FDA UDI
FDA Product Code
HSX FDA UDI
GMDN Term
Uncoated knee femur prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3520 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: Uncoated knee femur prosthesis, metallicCoated hip femur prosthesis, modularUncoated knee tibia prosthesis, metallic

Freedom by Maxx 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

K212870 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Maxx Orthopedics Inc.

Sources (1)

  • FDA UDI 4069a063-5ef3-4c7d-8d09-ab08b07af54e 35 fields · synced May 31, 2026