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OrthAlign Plus System — Orthalign, Inc. (510(k) K172462)

OrthAlign Plus System — Orthalign, Inc. (510(k) K172462) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: OrthAlign Plus System; Applicant: Orthalign, Inc.; Clearance track: 510(k).

Device nameOrthAlign Plus System
ApplicantOrthalign, Inc.
Clearance track510(k)
Submission numberK172462
DecisionSubstantially Equivalent
Decision date2017-11-22
Date received2017-08-14
Product codeOLO
Device class2
Medical specialtyNeurology
Applicant locationCA, US
SourceopenFDA device

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