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FDA 510(k)

GuideMia Ortho+

K-Number: K162850 · 2017-03-24

ApplicantGuidemia Technologies, LLC
Decision Date2017-03-24
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GuideMia Ortho+ is a medical device manufactured by Guidemia Technologies, LLC. It received FDA 510(k) clearance on 2017-03-24 under approval number K162850. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GuideMia Ortho+?

GuideMia Ortho+ is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Guidemia Technologies, LLC. The 510(k) number is K162850.

When was GuideMia Ortho+ approved by the FDA?

GuideMia Ortho+ received FDA 510(k) clearance on 2017-03-24, under approval number K162850.

What company makes GuideMia Ortho+?

GuideMia Ortho+ is manufactured by Guidemia Technologies, LLC.

What is the FDA product code for GuideMia Ortho+?

The FDA product code for GuideMia Ortho+ is PNN.

Related Devices (Code: PNN)

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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.

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