Ti3Z Cervical Interbody System
K-Number: K191354 · 2019-09-09
ApplicantZavation Medical Products, LLC
Decision Date2019-09-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Ti3Z Cervical Interbody System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2019-09-09 under approval number K191354. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ti3Z Cervical Interbody System?
Ti3Z Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2019-09-09. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K191354.
When was Ti3Z Cervical Interbody System approved by the FDA?
Ti3Z Cervical Interbody System received FDA 510(k) clearance on 2019-09-09, under approval number K191354.
What company makes Ti3Z Cervical Interbody System?
Ti3Z Cervical Interbody System is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for Ti3Z Cervical Interbody System?
The FDA product code for Ti3Z Cervical Interbody System is ODP.
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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.