Spine Wave Navigated Instruments
K-Number: K181596 · 2018-10-24
ApplicantSpine Wave, Inc.
Decision Date2018-10-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Spine Wave Navigated Instruments is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2018-10-24 under approval number K181596. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Spine Wave Navigated Instruments?
Spine Wave Navigated Instruments is a medical device that received FDA 510(k) clearance on 2018-10-24. It is manufactured by Spine Wave, Inc.. The 510(k) number is K181596.
When was Spine Wave Navigated Instruments approved by the FDA?
Spine Wave Navigated Instruments received FDA 510(k) clearance on 2018-10-24, under approval number K181596.
What company makes Spine Wave Navigated Instruments?
Spine Wave Navigated Instruments is manufactured by Spine Wave, Inc..
What is the FDA product code for Spine Wave Navigated Instruments?
The FDA product code for Spine Wave Navigated Instruments is OLO.
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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.