FDA 510(k)

Nanovis Intervertebral Body Fusion System and Forticore(R)

K-Number: K161485 · 2016-09-06

Decision Date2016-09-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Nanovis Intervertebral Body Fusion System and Forticore(R) is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2016-09-06 under approval number K161485. 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(R)?

Nanovis Intervertebral Body Fusion System and Forticore(R) is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Nanovis, LLC. The 510(k) number is K161485.

When was Nanovis Intervertebral Body Fusion System and Forticore(R) approved by the FDA?

Nanovis Intervertebral Body Fusion System and Forticore(R) received FDA 510(k) clearance on 2016-09-06, under approval number K161485.

What company makes Nanovis Intervertebral Body Fusion System and Forticore(R)?

Nanovis Intervertebral Body Fusion System and Forticore(R) is manufactured by Nanovis, LLC.

What is the FDA product code for Nanovis Intervertebral Body Fusion System and Forticore(R)?

The FDA product code for Nanovis Intervertebral Body Fusion System and Forticore(R) 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RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING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

K160874Nanovis Intervertebral Body Fusion System and FortiCore® 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

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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.