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510(k) K230463

NSite Scoliosis Assessment App by Nsite, Inc. — Product Code LDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2023
Date Received
February 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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