Orthofix Inc 3451 Plano Parkwaylewisville Tx 75056 Pma Numberp850007 Supplement Numbers046 Date Received03 16 2022 Decision Date06 14 2022 Product Code Lof Advisory Committee Orthopedic Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Orthofix Inc 3451 Plano Parkwaylewisville Tx 75056 Pma Numberp850007 Supplement Numbers046 Date Received03 16 2022 Decision Date06 14 2022 Product Code Lof Advisory Committee Orthopedic Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P850007S046 Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	PhysioStim®, SpinalStim®	2022-06-14