Identity
- Trade Name
- Freedom FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Tibial Articular Surface UC, Size B1-2, 11mm FDA UDI
- Model / Reference
- MLUCXB111-K FDA UDI
- Description
- Tibial Articular Surface UC, Size B1-2, 11mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811767028073 FDA UDI
- 510(k) Number
- K182574 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Tibial insert
Freedom by Maxx Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182574 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 307fdf14-aac4-4a0a-a666-8045734a2e66 34 fields · synced May 30, 2026