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510(k) K181339

Altus Spine Pedicle Screw System by Altus Partners, LLC — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2018
Date Received
May 21, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Altus Partners, LLC

  • K243419 — Altus Spine Navigation System (May 8, 2025)
  • K211027 — Altus Spine Pedicle Screw System (September 16, 2022)
  • K211837 — Altus Spine Interbody Standalone Fusion System (April 19, 2022)
  • K210887 — Altus Spine Sochi OCT Spinal System (August 20, 2021)
  • K200922 — Altus Spine HA Pedicle Screw System (January 26, 2021)
  • K200322 — Altus Spine Pedicle Screw System (June 2, 2020)
  • K183084 — Fuji Cervical Plate System (May 29, 2019)
  • K182406 — Altus Spine Interbody Fusion System (February 22, 2019)
  • K181281 — Altus Spine Pedicle Screw System (June 11, 2018)
  • K170553 — Altus Spine Interbody Fusion System (December 1, 2017)

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  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)