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FDA 510(k)

Valeo II Interbody Fusion Device System

K-Number: K161405 · 2016-08-19

ApplicantAmedica Corp.
Decision Date2016-08-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Valeo II Interbody Fusion Device System is a medical device manufactured by Amedica Corp.. It received FDA 510(k) clearance on 2016-08-19 under approval number K161405. 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 Valeo II Interbody Fusion Device System?

Valeo II Interbody Fusion Device System is a medical device that received FDA 510(k) clearance on 2016-08-19. It is manufactured by Amedica Corp.. The 510(k) number is K161405.

When was Valeo II Interbody Fusion Device System approved by the FDA?

Valeo II Interbody Fusion Device System received FDA 510(k) clearance on 2016-08-19, under approval number K161405.

What company makes Valeo II Interbody Fusion Device System?

Valeo II Interbody Fusion Device System is manufactured by Amedica Corp..

What is the FDA product code for Valeo II Interbody Fusion Device System?

The FDA product code for Valeo II Interbody Fusion Device System is MAX.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Amedica Corp.

K173453Valeo® C+CSC with Lumen Interbody Fusion Device

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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