Identity
- Trade Name
- UCP Centralizer with cement restrictor FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- UCP Centralizer with cement restrictor, 8C FDA UDI
- Model / Reference
- 1907-3008 FDA UDI
- Description
- UCP Centralizer with cement restrictor, 8C FDA UDI
Identifiers
- Catalog Number
- 1907-3008 FDA UDI
- Primary DI / UDI-DI
- 04711605569316 FDA UDI
- 510(k) Number
- K152530 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDILWJ FDA UDIJDI FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3360 FDA UDI888.3350 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: Metal-on-polyethylene total hip prosthesis
UCP Centralizer with cement restrictor by United Orthopedic Corp. — 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
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · 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
K152530 also covers:
- Cement restrictor, I type — UNITED ORTHOPEDIC CORP.
- Cement restrictor, I type — UNITED ORTHOPEDIC CORP.
- Cement restrictor, I type — UNITED ORTHOPEDIC CORP.
- Cement restrictor, I type — UNITED ORTHOPEDIC CORP.
- Cement restrictor, I type — UNITED ORTHOPEDIC CORP.
- Cement restrictor, I type — UNITED ORTHOPEDIC CORP.
- UCP Centralizer with cement restrictor — UNITED ORTHOPEDIC CORP.
- UCP Centralizer with cement restrictor — UNITED ORTHOPEDIC CORP.
- UCP Centralizer with cement restrictor — UNITED ORTHOPEDIC CORP.
- UCP Centralizer with cement restrictor — UNITED ORTHOPEDIC CORP.
- UCP Centralizer with cement restrictor — UNITED ORTHOPEDIC CORP.
- UCP Stem — UNITED ORTHOPEDIC CORP.
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
- United Orthopedic Corp.
Sources (1)
- FDA UDI 215204d8-43eb-48a2-9e5e-e99eb5455473 37 fields · synced Jun 8, 2026