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Ceramic Femoral Head BIOLOX® Delta 12/14XL

FDA UDI

Class II (US FDA UDI)

by United Orthopedic Corp.

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.φ36mm, 12/14- XL FDA UDI
Model / Reference
1203-5636 FDA UDI
Description
Ceramic Femoral Head, Delta, O.D.φ36mm, 12/14- XL FDA UDI

Identifiers

Catalog Number
1203-5636 FDA UDI
Primary DI / UDI-DI
04712771495300 FDA UDI
510(k) Number
K112463 FDA UDI
FDA Product Code
LZO FDA UDI
LPH FDA UDI
MEH FDA UDI
GMDN Term
Ceramic-on-polyethylene total hip prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3358 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 — 36 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 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

K112463 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 ddad693e-f7cc-49c8-93f9-7518816c5c12 37 fields · synced Jun 8, 2026