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Genius-A Instrument Case 2 Tibia 122-15-0451

by Signature Orthopaedics Pty Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

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 Number09348215057077 UDI-DI Date4 Nov 2019ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0833-2019 FDA Class II initiated 10 Dec 2018 on shared 510(k) K170613
    • Terminated Z-0834-2019 FDA Class II initiated 10 Dec 2018 on shared 510(k) K170613

    Product mix up

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Genius-A Instrument Case 2 Tibia
Generic Name
Instrument tray, reusable
Model / Reference
122-15-0451
Primary DI / UDI-DI
09348215057077
510(k) Number
FDA Product Code
KCT
GMDN Term
Instrument tray, reusable
Device Class
Class II
Regulation Number
880.6850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K170613)

Show all (12)

Other devices from Signature Orthopaedics Pty Ltd

See all devices from Signature Orthopaedics Pty Ltd →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No