Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tranquil-C Interbody System

K-Number: K240416 · 2024-03-12

ApplicantNexus Spine, LLC
Decision Date2024-03-12
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tranquil-C Interbody System is a medical device manufactured by Nexus Spine, LLC. It received FDA 510(k) clearance on 2024-03-12 under approval number K240416. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tranquil-C Interbody System?

Tranquil-C Interbody System is a medical device that received FDA 510(k) clearance on 2024-03-12. It is manufactured by Nexus Spine, LLC. The 510(k) number is K240416.

When was Tranquil-C Interbody System approved by the FDA?

Tranquil-C Interbody System received FDA 510(k) clearance on 2024-03-12, under approval number K240416.

What company makes Tranquil-C Interbody System?

Tranquil-C Interbody System is manufactured by Nexus Spine, LLC.

What is the FDA product code for Tranquil-C Interbody System?

The FDA product code for Tranquil-C Interbody System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Nexus Spine, LLC

K160820PressON Pro Spinal Fixation System K170297Tranquil Interbody System K181621Stable-C Interbody System K181702Tranquil-L Interbody System K181483Tranquil Interbody System K212498Stable-L Standalone Lumbar Interbody System

View all 16 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑