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FDA 510(k)

Ti 3Z Interbody System

K-Number: K180076 · 2018-07-27

ApplicantZavation Medical Products, LLC
Decision Date2018-07-27
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ti 3Z Interbody System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2018-07-27 under approval number K180076. 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 Ti 3Z Interbody System?

Ti 3Z Interbody System is a medical device that received FDA 510(k) clearance on 2018-07-27. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K180076.

When was Ti 3Z Interbody System approved by the FDA?

Ti 3Z Interbody System received FDA 510(k) clearance on 2018-07-27, under approval number K180076.

What company makes Ti 3Z Interbody System?

Ti 3Z Interbody System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Ti 3Z Interbody System?

The FDA product code for Ti 3Z Interbody System is MAX.

Related Clinical Trials

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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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