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Initia Total Hip System GMH02-200026

by Kyocera Corporation

Initia Total Hip System GMH02-200026 is a Class II device made by Kyocera Corporation, listed in FDA GUDID since 21 Feb 2017 (UDI-DI 04547898306471), 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 Number04547898306471 UDI-DI Date21 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  • Withdrawn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
Metal-on-polyethylene total hip prosthesis
Model / Ref / Catalog
GMH02-200026
Primary DI / UDI-DI
04547898306471
FDA product code
LPH
GMDN term
Metal-on-polyethylene total hip prosthesis
Device class
Class II
Regulation number
888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metal-on-polyethylene total hip prosthesis

Other devices from Kyocera Corporation

See all devices from Kyocera Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)