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FDA 510(k) K130387, ORTHOALIGN PLUS SYSTEM, by Orthalign, Inc.

FDA 510(k) K130387, ORTHOALIGN PLUS SYSTEM, by Orthalign, Inc.

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510(K) Number: K130387
Device Name: ORTHOALIGN PLUS SYSTEM
Manufacturer: Orthalign, Inc.
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: KXA
Date Received: 02/15/2013
Decision Date: 11/08/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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