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510(k) K240416

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

K240416 is an FDA 510(k) premarket notification submitted by Nexus Spine, LLC for the device "Tranquil-C Interbody System". The FDA issued a decision of Substantially Equivalent on March 12, 2024. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Nexus Spine, LLC has at least 10 other 510(k) clearances on record.

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

  • K261279 — DeltaNEC Interbody System (June 22, 2026)
  • K253331 — PressON Spinal Fixation System (October 14, 2025)
  • K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
  • K241467 — Stable-C Interbody System (July 17, 2024)
  • K233375 — Tranquil-L Interbody System (March 20, 2024)
  • 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)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources