b-ONE™ Primary Acetabular System

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: b-ONE™ Primary Acetabular System FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Device Name: Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size E FDA UDI
Model / Reference: 881201281E FDA UDI
Description: Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 28mm Inner Diameter, Size E FDA UDI

Identifiers

Catalog Number: 881201281E FDA UDI
Primary DI / UDI-DI: 00843575102393 FDA UDI
FDA Product Code: MEH FDA UDI
HWC FDA UDI
LZO FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner 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: Non-constrained polyethylene acetabular liner

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

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

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RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
PRIME — MicroPort Orthopedics Inc. · Class II
G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
PINNACLE — DEPUY ORTHOPAEDICS, INC. · 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 c96bf13e-69ec-429c-b70a-4651cef727bb 34 fields · synced May 30, 2026