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FDA 510(k)

Tranquil Interbody System

K-Number: K181483 · 2018-08-27

ApplicantNexus Spine, LLC
Decision Date2018-08-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tranquil Interbody System is a medical device manufactured by Nexus Spine, LLC. It received FDA 510(k) clearance on 2018-08-27 under approval number K181483. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tranquil Interbody System?

Tranquil Interbody System is a medical device that received FDA 510(k) clearance on 2018-08-27. It is manufactured by Nexus Spine, LLC. The 510(k) number is K181483.

When was Tranquil Interbody System approved by the FDA?

Tranquil Interbody System received FDA 510(k) clearance on 2018-08-27, under approval number K181483.

What company makes Tranquil Interbody System?

Tranquil Interbody System is manufactured by Nexus Spine, LLC.

What is the FDA product code for Tranquil Interbody System?

The FDA product code for Tranquil Interbody System is MAX.

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 K212498Stable-L Standalone Lumbar Interbody System K233234PressON Spinal Fixation System

View all 16 devices →

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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.

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