Home / 510(k) Clearances / K151648

510(k) K151648

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2015
Date Received
June 18, 2015
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)
  • K181339 — Altus Spine Pedicle Screw System (July 24, 2018)
  • K181281 — Altus Spine Pedicle Screw System (June 11, 2018)

Other clearances for product code NKB

  • K254274 — ARx® SAI Implant System (April 16, 2026)
  • K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (April 3, 2026)
  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • 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)