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Ceramic Femoral Head BIOLOX® Delta 12/14S

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name
Ceramic Femoral Head BIOLOX® Delta 12/14S FDA UDI
Generic Name
Ceramic-on-ceramic total hip prosthesis FDA UDI
Device Name
Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- S FDA UDI
Model / Reference
1203-5032 FDA UDI
Description
Ceramic Femoral Head, Delta, O.D.φ32mm, 12/14- S FDA UDI

Identifiers

Catalog Number
1203-5032 FDA UDI
Primary DI / UDI-DI
04712771494914 FDA UDI
510(k) Number
K103497 FDA UDI
FDA Product Code
MEH FDA UDI
LPH FDA UDI
LWJ FDA UDI
GMDN Term
Ceramic-on-ceramic total hip prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3358 FDA UDI
888.3360 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 12/14S by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ceramic-on-ceramic total hip prosthesis.

Cleared under the same submission

K103497 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (1)

  • FDA UDI 15eecd6c-3d78-4e56-8100-62ab30c39ad3 37 fields · synced May 31, 2026