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Vector™ Pedicle Screw System LS-749

by INNO Holdings, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM711LS7490 UDI-DI Date5 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2859-2026 FDA Class II initiated 22 May 2026

    Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vector™ Pedicle Screw System
Generic Name
Orthopaedic counter-torque/rod-pushing instrument
Model / Reference
LS-749
Primary DI / UDI-DI
M711LS7490
510(k) Number
FDA Product Code
NKB, KWP
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument
Device Class
Class II
Regulation Number
888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K241276)

Show all (12)

Other devices from INNO Holdings, Inc.

See all devices from INNO Holdings, Inc. →

Properties

  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No