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510(k) K132280

ALTUS SPINE PEDICLE SCREW SYSTEM by Altus Partners — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2013
Date Received
July 23, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Altus Partners

  • 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 MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)