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510(k) K202637

F3D Corpectomy System by Corelink, LLC — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
September 11, 2020
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 Corelink, LLC

  • K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Or (December 8, 2023)
  • K231494 — CoreLink Robotic Navigation Instruments (October 27, 2023)
  • K232116 — CoreLink Navigation Instruments (August 16, 2023)
  • K230329 — F3D Interbody System (June 6, 2023)
  • K230880 — CoreLink Navigation Instruments (May 2, 2023)
  • K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System (March 21, 2023)
  • K221776 — NextGen Pedicle Screw System (August 9, 2022)
  • K220973 — CoreLink Navigation Instruments (June 1, 2022)
  • K211417 — F3D-C2 Cervical Stand-Alone System (February 4, 2022)
  • K214059 — CoreLink Navigation Instruments (January 19, 2022)

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)
  • 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)
  • K192117 — Small VBR™ (November 1, 2019)