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Anterior Approach Instrument Tray - Retractors 112-25-0101

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 Number09348215057961 UDI-DI Date5 Nov 2019ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1694-2021 FDA Class II initiated 20 Apr 2021 on shared 510(k) K121297

    Product mislabeled, with the incorrect product inside the package.

    • Terminated Z-0920-2018 FDA Class II initiated 2 Feb 2018 on shared 510(k) K121297

    This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.

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  • Withdrawn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
Anterior Approach Instrument Tray - Retractors
Generic Name
Instrument tray, reusable
Model / Reference
112-25-0101
Primary DI / UDI-DI
09348215057961
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 (K121297)

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