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Veritas Instrumentation 6500-1120

by Restor3D

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840097503677 UDI-DI Date16 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2987-2026 FDA Class II initiated 30 Jun 2026

    Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Veritas Instrumentation
Generic Name
Orthopaedic guidewire, single-use
Model / Reference
6500-1120
Primary DI / UDI-DI
00840097503677
510(k) Number
FDA Product Code
PHX
GMDN Term
Orthopaedic guidewire, single-use
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243643)

Show all (12)

Other devices from Restor3D

See all devices from Restor3D →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: 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