b-ONE™ 12/14 Taper Femoral Head

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: b-ONE™ 12/14 Taper Femoral Head FDA UDI
Generic Name: Ceramic femoral head prosthesis FDA UDI
Device Name: Femoral Head, BIOLOX® delta ceramic; 28mm Diameter, -3.5mm Neck Length FDA UDI
Model / Reference: 397175445 FDA UDI
Description: Femoral Head, BIOLOX® delta ceramic; 28mm Diameter, -3.5mm Neck Length FDA UDI

Identifiers

Catalog Number: 397175445 FDA UDI
Primary DI / UDI-DI: 00843575100009 FDA UDI
FDA Product Code: MEH FDA UDI
HWC FDA UDI
LZO FDA UDI
GMDN Term: Ceramic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3040 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

Category: Ceramic femoral head prosthesis

b-ONE™ 12/14 Taper Femoral Head by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ceramic femoral head prosthesis.

Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
ELEC(R)plus — HiPer Medical AG · Class III
BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
InSitu Hip System — Nextstep Arthropedix · Class II
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

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: b-ONE Ortho Corp.

Sources (1)

FDA UDI 39b42827-2df5-4530-b9c0-5f3e306b44ee 34 fields · synced Jun 8, 2026