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EXULT Knee Replacement System K3.IBN.5079-24T

by Corentec Co., Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08800017265087 UDI-DI Date10 Jan 2020ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
EXULT Knee Replacement System
Generic Name
Tibial insert
Model / Reference
K3.IBN.5079-24T
Primary DI / UDI-DI
08800017265087
510(k) Number
FDA Product Code
JWH
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Knee tibia prosthesis trial, reusable

Cleared under the same submission (K192507)

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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