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Kyocera Medical Technologies, Inc. Initia T3

by Kyocera Medical Technologies, Inc. 194 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841523166442 UDI-DI Date2 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Kyocera Medical Technologies, Inc.
Generic Name
Acetabular shell
Model / Ref / Catalog
Initia T3, 1502-121-054
Primary DI / UDI-DI
00841523166442
510(k) Number
FDA Product Code
LPH, LZO
GMDN Term
Acetabular shell
Device Class
Class II
Regulation Number
888.3358, 888.3353
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242045)

Show all (12)

Other devices from Kyocera Medical Technologies, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No