Identity
- Trade Name
- Freedom FDA UDI
- Generic Name
- Uncoated knee femur prosthesis, metallic FDA UDI
- Device Name
- Unicondylar Tibial Liner Size 3, 10mm, Right Medial/Left Lateral FDA UDI
- Model / Reference
- DURMLL310-UK FDA UDI
- Description
- Unicondylar Tibial Liner Size 3, 10mm, Right Medial/Left Lateral FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810008127797 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.
- Natural-Knee® — Zimmer, Inc. · Class II
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- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Biomet® Knee System — Biomet Orthopedics, Inc. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- CKS Plus — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Cleared under the same submission
K212870 also covers:
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Maxx Orthopedics Inc.
Sources (1)
- FDA UDI bef3b9be-6544-47fb-923b-17084a1fb2e4 35 fields · synced May 30, 2026