Home / 510(k) Clearances / K150036

510(k) K150036

Blue Mountain Cervical Plate System by Spineway — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2015
Date Received
January 9, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Spineway

  • K231658 — VEOS Spinal Fixation System (October 10, 2023)
  • K191726 — mont blanc & mont blanc MIS Spinal Systems (September 12, 2019)
  • K162694 — Ayers Rock Cervical interbody fusion system (January 12, 2017)
  • K161387 — Mont Blanc and Mont Blanc MIS Spinal Systems (August 4, 2016)
  • K152355 — Twin Peaks Lumbar Interbody Fusion System (December 10, 2015)
  • K150185 — Mont Blanc Spinal System (May 12, 2015)

Other clearances for product code KWQ

  • K260697 — VyPlate™ Anterior Cervical Plate System (March 27, 2026)
  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)