Inbrace Orthodontic System
K-Number: K203442 · 2021-02-19
ApplicantSwift Health Systems, Inc.
Decision Date2021-02-19
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Inbrace Orthodontic System is a medical device manufactured by Swift Health Systems, Inc.. It received FDA 510(k) clearance on 2021-02-19 under approval number K203442. 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 Inbrace Orthodontic System?
Inbrace Orthodontic System is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Swift Health Systems, Inc.. The 510(k) number is K203442.
When was Inbrace Orthodontic System approved by the FDA?
Inbrace Orthodontic System received FDA 510(k) clearance on 2021-02-19, under approval number K203442.
What company makes Inbrace Orthodontic System?
Inbrace Orthodontic System is manufactured by Swift Health Systems, Inc..
What is the FDA product code for Inbrace Orthodontic System?
The FDA product code for Inbrace Orthodontic System is 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.