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LineSider LS-SC7A7535

by Integrity Implants Inc.

LineSider LS-SC7A7535 is a Class II device made by Integrity Implants Inc., cleared under FDA 510(k) K190360 on 21 Jun 2019 and listed in FDA GUDID since 20 Mar 2020 (UDI-DI 00818613021813), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K190360

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 Number00818613021813 UDI-DI Date20 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190360 Date21 Jun 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190360 decided 21 Jun 2019 Active
  • FDA GUDID UDI-DI 00818613021813 listed 20 Mar 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190360
  2. Listed FDA GUDID 00818613021813

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  • Withdrawn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-SC7A7535
Description
Dual Lead Shank - Non-Cannulated - 7.1mm Ball 7.5mm x 35mm
Primary DI / UDI-DI
00818613021813
510(k) Number
FDA product code
KWP, NKB
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3050, 888.3070
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 (K190360)

and 8 more cleared under K190360

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)