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Initia Total Hip System 1183-6004-01

by Kyocera Medical Corporation

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04580810066824 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 / Reference
1183-6004-01
Description
"FEMORAL BROACH TRAY "
Primary DI / UDI-DI
04580810066824
FDA Product Code
LPH
GMDN Term
Joint prosthesis implantation kit, reusable
Device Class
Class II
Regulation Number
888.3358
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Kyocera Medical Corporation

See all devices from Kyocera Medical Corporation →

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No