Zavation Spinal System
K-Number: K211113 · 2021-07-12
ApplicantZavation Medical Products, LLC
Decision Date2021-07-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Zavation Spinal System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2021-07-12 under approval number K211113. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zavation Spinal System?
Zavation Spinal System is a medical device that received FDA 510(k) clearance on 2021-07-12. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K211113.
When was Zavation Spinal System approved by the FDA?
Zavation Spinal System received FDA 510(k) clearance on 2021-07-12, under approval number K211113.
What company makes Zavation Spinal System?
Zavation Spinal System is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for Zavation Spinal System?
The FDA product code for Zavation Spinal System is NKB.
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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.