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510(k) K240416

Tranquil-C Interbody System by Nexus Spine, LLC — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2024
Date Received
February 12, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Nexus Spine, LLC

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  • K233234 — PressON Spinal Fixation System (October 26, 2023)
  • K231486 — Stable-L Standalone Lumbar Interbody System (October 12, 2023)
  • K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (September 18, 2023)
  • K231763 — Stable-C Interbody System (August 21, 2023)
  • K223529 — PressON Spinal Fixation System (May 2, 2023)
  • K223627 — PreView-III™ Anterior Cervical Plate System (February 2, 2023)

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  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)
  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
  • K250769 — Dakota LP System (November 24, 2025)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)