Leva Spacer System
K-Number: K153222 · 2016-04-15
ApplicantSpine Wave, Inc.
Decision Date2016-04-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Leva Spacer System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval number K153222. 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 Leva Spacer System?
Leva Spacer System is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Spine Wave, Inc.. The 510(k) number is K153222.
When was Leva Spacer System approved by the FDA?
Leva Spacer System received FDA 510(k) clearance on 2016-04-15, under approval number K153222.
What company makes Leva Spacer System?
Leva Spacer System is manufactured by Spine Wave, Inc..
What is the FDA product code for Leva Spacer System?
The FDA product code for Leva Spacer System is MAX.
Other Devices by Spine Wave, Inc.
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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.