Identity
- Trade Name
- Libertas FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- HXLPE MH/32 10° Oblique Liner FDA UDI
- Model / Reference
- MO-MLJD-MH/32 FDA UDI
- Description
- HXLPE MH/32 10° Oblique Liner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840333903063 FDA UDI
- 510(k) Number
- K180973 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Metal-on-polyethylene total hip prosthesis
Libertas by Maxx Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-on-polyethylene total hip prosthesis.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
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- Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- "UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP. · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
Cleared under the same submission
K180973 also covers:
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — MAXX ORTHOPEDICS INC.
- Libertas — 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 d8243186-e542-488e-aa83-11faa90c7e93 35 fields · synced May 31, 2026