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Initia Total Hip System TJ34475

by Kyocera Corporation

Initia Total Hip System TJ34475 is a Class I device made by Kyocera Corporation, listed in FDA GUDID since 20 Feb 2017 (UDI-DI 04547898735530), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04547898735530 UDI-DI Date20 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Initia Total Hip System
Generic name
Joint prosthesis implantation kit, reusable
Model / Ref / Catalog
TJ34475
Primary DI / UDI-DI
04547898735530
FDA product code
LXH
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Joint prosthesis implantation kit, reusable

Similar devices in this category

Other devices filed under Joint prosthesis implantation kit, reusable.

Other devices from Kyocera Corporation

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (11, all answered No)