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FDA 510(k)

Tranquil-L Interbody System

K-Number: K181702 · 2018-09-21

ApplicantNexus Spine, LLC
Decision Date2018-09-21
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tranquil-L Interbody System is a medical device manufactured by Nexus Spine, LLC. It received FDA 510(k) clearance on 2018-09-21 under approval number K181702. 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-L Interbody System?

Tranquil-L Interbody System is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Nexus Spine, LLC. The 510(k) number is K181702.

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

Tranquil-L Interbody System received FDA 510(k) clearance on 2018-09-21, under approval number K181702.

What company makes Tranquil-L Interbody System?

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

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

The FDA product code for Tranquil-L 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 K181483Tranquil Interbody System K212498Stable-L Standalone Lumbar Interbody System K233234PressON Spinal Fixation System

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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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