Navio
K-Number: K160537 · 2016-05-19
ApplicantBlue Belt Technologies, Inc.
Decision Date2016-05-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Navio is a medical device manufactured by Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-19 under approval number K160537. 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 Navio?
Navio is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Blue Belt Technologies, Inc.. The 510(k) number is K160537.
When was Navio approved by the FDA?
Navio received FDA 510(k) clearance on 2016-05-19, under approval number K160537.
What company makes Navio?
Navio is manufactured by Blue Belt Technologies, Inc..
What is the FDA product code for Navio?
The FDA product code for Navio is OLO.
Other Devices by Blue Belt Technologies, Inc.
Related Devices (Code: OLO)
K162375Envision 3D: Image Guidance System7D Surgical, Inc.
K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG
K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.
K160385Precision ScrewCryptych Pty, Ltd.
K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC
K153240Styrker OrthoMap Express Knee SystemStryker Corporate
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.