Tranquil-C Interbody System— 510(k) K240416

Name: FDA 510(k) clearance K240416
Creator: U.S. Food and Drug Administration
Published: 2024-03-12

Substantially Equivalent

Nexus Spine, LLC

FDA 510(k) clearance K240416 for Tranquil-C Interbody System, Substantially Equivalent on 2024-03-12. Applicant: Nexus Spine, LLC. Device class: 2.

Clearance details

Applicant: Nexus Spine, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-02-12
Decision date: 2024-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Nexus Spine, LLC

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K243934 — Stable-L Lumbar Interbody System2025-04-30
K241467 — Stable-C Interbody System2024-07-17
K233375 — Tranquil-L Interbody System2024-03-20
K233234 — PressON Spinal Fixation System2023-10-26
K231486 — Stable-L Standalone Lumbar Interbody System2023-10-12

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.