Home / 510(k) Clearances / K180665

510(k) K180665

SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System by K2m, LLC — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2018
Date Received
March 14, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by K2m, LLC

  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K202528 — Cannulated Power Driver Attachment (October 26, 2020)
  • K201006 — K2M Navigation Instruments (August 7, 2020)
  • K193203 — MOJAVE Expandable Interbody System (February 18, 2020)
  • K193129 — Yukon OCT Spinal System (February 7, 2020)
  • K192911 — Brainlab Compatible K2M Navigation Instruments (November 14, 2019)
  • K190179 — SAHARA Stabilization System (October 3, 2019)
  • K190584 — CAYMAN LP Plate System (May 15, 2019)

Other clearances for product code MQP

  • K253158 — VyBrate™ VBR System (January 7, 2026)
  • K241468 — Vertiwedge® Intraosseous System (November 7, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable (February 26, 2020)