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LineSider LS-N6RA6525

by Highridge Medical, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03662663099813 UDI-DI Date3 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · FDA

    • Terminated Z-0421-2023 FDA Class II initiated 3 Aug 2022 on shared 510(k) K203367

    Potential for intraoperative screw head separation at weld location.

  • 3 recalls, same reason

    • Terminated Z-0418-2023 FDA Class II initiated 27 Jan 2022 on shared 510(k) K203367
    • Terminated Z-0419-2023 FDA Class II initiated 27 Jan 2022 on shared 510(k) K203367
    • Terminated Z-0420-2023 FDA Class II initiated 27 Jan 2022 on shared 510(k) K203367

    Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

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  • Withdrawn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
LineSider
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
LS-N6RA6525
Primary DI / UDI-DI
03662663099813
510(k) Number
FDA Product Code
KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K203367)

Show all (12)

Other devices from Highridge Medical, LLC

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: 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