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Tibial Trial Insert Base Size 4 122-15-0500

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 Number09348215073961 UDI-DI Date24 Jun 2020ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0833-2019 FDA Class II initiated 10 Dec 2018
    • Terminated Z-0834-2019 FDA Class II initiated 10 Dec 2018

    Product mix up

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tibial Trial Insert Base Size 4
Generic Name
Surgical implant template, reusable
Model / Reference
122-15-0500
Primary DI / UDI-DI
09348215073961
510(k) Number
FDA Product Code
JWH
GMDN Term
Surgical implant template, reusable
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical implant template, reusable

Cleared under the same submission (K170613)

Show all (12)

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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