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Ceramic Femoral Head BIOLOX® Delta 12/14XL
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K103497
Identity
- Trade Name
- Ceramic Femoral Head BIOLOX® Delta 12/14XL FDA UDI
- Generic Name
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- XL FDA UDI
- Model / Reference
- 1203-5632 FDA UDI
- Description
- Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- XL FDA UDI
Identifiers
- Catalog Number
- 1203-5632 FDA UDI
- Primary DI / UDI-DI
- 04712771494969 FDA UDI
- 510(k) Number
- K103497 FDA UDI
- FDA Product Code
- MEH FDA UDILPH FDA UDILWJ FDA UDI
- GMDN Term
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 FDA UDI888.3360 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
Dimensions & Sizes
- Size
- Outer Diameter — 32 Millimeter FDA UDI
Category: Ceramic-on-polyethylene total hip prosthesisCeramic-on-ceramic total hip prosthesis
Ceramic Femoral Head BIOLOX® Delta 12/14XL by United Orthopedic Corp. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic-on-ceramic total hip prosthesis.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- Ceramic Femoral Head BIOLOX® Delta 12/14XL — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II HA Cup, No-Hole — UNITED ORTHOPEDIC CORP. · Class II
Cleared under the same submission
K103497 also covers:
- Ceramic Femoral Head BIOLOX® Delta 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14S — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Forte 12/14S — UNITED ORTHOPEDIC CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103497 | Class II | Active |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI c7218ffe-a9f7-4d68-8065-93cfccd7c4e5 61 fields · synced Jun 18, 2026
- FDA 510(k) K103497 1 fields · synced May 25, 2026