BIOLOX® delta Option

FDA UDI

Class II (US FDA UDI)

by Biomet Uk Ltd

Identity

Trade Name: BIOLOX® delta Option FDA UDI
Generic Name: Ceramic femoral head prosthesis FDA UDI
Model / Reference: 650-1056 FDA UDI

Identifiers

Catalog Number: 650-1056 FDA UDI
Primary DI / UDI-DI: 00887868271380 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
OQH FDA UDI
LWJ FDA UDI
OQG FDA UDI
JDI FDA UDI
MAY FDA UDI
OQI FDA UDI
GMDN Term: Ceramic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3353 FDA UDI
888.3350 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Ceramic femoral head prosthesis

BIOLOX® delta Option by Biomet Uk Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ceramic femoral head prosthesis.

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Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
InSitu Hip System — Nextstep Arthropedix · Class II
SYNERGY — Smith & Nephew, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
BENCOX Hip System — Corentec Co., Ltd · Class II

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: Biomet Uk Ltd

Sources (1)

FDA UDI 0a986dbd-bc31-4e4a-99f1-3695e4a3c689 35 fields · synced May 31, 2026