FDA 510(k)

GuideMia Ortho+

K-Number: K162850 · 2017-03-24

Decision Date2017-03-24

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GuideMia Ortho+ is the device name listed in this FDA 510(k) record. The listed applicant is Guidemia Technologies, LLC. It received FDA 510(k) clearance on 2017-03-24 under 510(k) 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. The listed applicant is Guidemia Technologies, LLC. The 510(k) number is K162850.

When did GuideMia Ortho+ receive FDA 510(k) clearance?

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

Who is the listed applicant for GuideMia Ortho+?

The FDA 510(k) record lists Guidemia Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GuideMia Ortho+?

The FDA product code for GuideMia Ortho+ is PNN.

Related Devices (Code: PNN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLC K253343Celebrace SoftwareCelebrace K250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.

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.