Skip to content

LineSider LS-N6SA5035

by Integrity Implants Inc.

LineSider LS-N6SA5035 is a Class II device made by Integrity Implants Inc., cleared under FDA 510(k) K203367 on 3 Dec 2020 and listed in FDA GUDID since 18 Feb 2021 (UDI-DI 00818613027624), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

510(k) K203367

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818613027624 UDI-DI Date18 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK203367 Date3 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203367 decided 3 Dec 2020 Active
  • FDA GUDID UDI-DI 00818613027624 listed 18 Feb 2021 Listed

Recalls

4 recalls · FDA

    • Terminated Z-0421-2023 FDA Class II initiated 3 Aug 2022

    Potential for intraoperative screw head separation at weld location.

  • 3 recalls, same reason

    • Terminated Z-0418-2023 FDA Class II initiated 27 Jan 2022
    • Terminated Z-0419-2023 FDA Class II initiated 27 Jan 2022
    • Terminated Z-0420-2023 FDA Class II initiated 27 Jan 2022

    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.

Timeline

6 dated events

  1. Cleared FDA 510(k) K203367
  2. Listed FDA GUDID 00818613027624
  3. Recall initiated FDA recalls Z-0418-2023
  4. Recall initiated FDA recalls Z-0419-2023
  5. Recall initiated FDA recalls Z-0420-2023
  6. Recall initiated FDA recalls Z-0421-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LineSider
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
LS-N6SA5035
Primary DI / UDI-DI
00818613027624
510(k) Number
FDA product code
NKB, KWP
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K203367)

and 8 more cleared under K203367

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Integrity Implants Inc.

See all devices from Integrity Implants Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)