Juveno™ Femoral Hip System

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: Juveno™ Femoral Hip System FDA UDI
Generic Name: Press-fit femoral stem prosthesis FDA UDI
Device Name: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 7, Standard (132 degree) Offset FDA UDI
Model / Reference: 8810003207 FDA UDI
Description: Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 7, Standard (132 degree) Offset FDA UDI

Identifiers

Catalog Number: 8810003207 FDA UDI
Primary DI / UDI-DI: 00843575103895 FDA UDI
FDA Product Code: HWC FDA UDI
MEH FDA UDI
LZO FDA UDI
GMDN Term: Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3353 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: Press-fit femoral stem prosthesis

Juveno™ Femoral Hip System by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Press-fit femoral stem prosthesis.

Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II
Novation — Exactech, Inc. · Class II
Restoration — Howmedica Osteonics Corp. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class III
Restoration — Howmedica Osteonics Corp. · Class II
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Accolade — Howmedica Osteonics Corp. · 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 4241d076-2100-4007-b721-2cec299ed0ea 34 fields · synced Jun 6, 2026