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FDA 510(k)

Nanovis Intervertebral Body Fusion System and FortiCore®

K-Number: K160874 · 2016-06-28

ApplicantNanovis, LLC
Decision Date2016-06-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Nanovis Intervertebral Body Fusion System and FortiCore® is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2016-06-28 under approval number K160874. 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 Nanovis Intervertebral Body Fusion System and FortiCore®?

Nanovis Intervertebral Body Fusion System and FortiCore® is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Nanovis, LLC. The 510(k) number is K160874.

When was Nanovis Intervertebral Body Fusion System and FortiCore® approved by the FDA?

Nanovis Intervertebral Body Fusion System and FortiCore® received FDA 510(k) clearance on 2016-06-28, under approval number K160874.

What company makes Nanovis Intervertebral Body Fusion System and FortiCore®?

Nanovis Intervertebral Body Fusion System and FortiCore® is manufactured by Nanovis, LLC.

What is the FDA product code for Nanovis Intervertebral Body Fusion System and FortiCore®?

The FDA product code for Nanovis Intervertebral Body Fusion System and FortiCore® 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 NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Nanovis, LLC

K161485Nanovis Intervertebral Body Fusion System and Forticore(R) K171312FortiCore® K191822Nano FortiCore, FortiCore K203452Nano FortiFix® System K230936Anatomic PEEK™ Cervical Fusion System with Nanotechnology K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology

View all 7 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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