Spinal Elements Navigated Instruments
K-Number: K190881 · 2019-12-19
ApplicantSpinal Elements, Inc.
Decision Date2019-12-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Spinal Elements Navigated Instruments is a medical device manufactured by Spinal Elements, Inc.. It received FDA 510(k) clearance on 2019-12-19 under approval number K190881. 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 Spinal Elements Navigated Instruments?
Spinal Elements Navigated Instruments is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Spinal Elements, Inc.. The 510(k) number is K190881.
When was Spinal Elements Navigated Instruments approved by the FDA?
Spinal Elements Navigated Instruments received FDA 510(k) clearance on 2019-12-19, under approval number K190881.
What company makes Spinal Elements Navigated Instruments?
Spinal Elements Navigated Instruments is manufactured by Spinal Elements, Inc..
What is the FDA product code for Spinal Elements Navigated Instruments?
The FDA product code for Spinal Elements 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.