Kosmo Femoral Hip System

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: Kosmo Femoral Hip System FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: Cement Restrictor Trial 15.25mm O.D. FDA UDI
Model / Reference: 8819040005 FDA UDI
Description: Cement Restrictor Trial 15.25mm O.D. FDA UDI

Identifiers

Catalog Number: 8819040005 FDA UDI
Primary DI / UDI-DI: 00843575120397 FDA UDI
FDA Product Code: LZO FDA UDI
MEH FDA UDI
JDI FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

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

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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 7068e73f-a049-43c2-ae92-195918fa5cb5 34 fields · synced Jun 7, 2026