Initia Total Hip System

FDA UDI

Class II (US FDA UDI)

by Kyocera Corporation

Identity

Trade Name: Initia Total Hip System FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: INITIA SHELL TRIAL 64 FDA UDI
Model / Reference: TJ33442-27 FDA UDI
Description: INITIA SHELL TRIAL 64 FDA UDI

Identifiers

Catalog Number: TJ33442-27 FDA UDI
Primary DI / UDI-DI: 04547898735967 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

Initia Total Hip System by Kyocera Corporation — 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: Kyocera Corporation

Sources (1)

FDA UDI 0cecd51a-dc2e-432b-a50b-69ee7998ea47 36 fields · synced May 31, 2026