Medtronic Sofamor Danek Usa Inc 1800 Pyramid Placememphis Tn 38132 Pma Numberp000058 Supplement Numbers087 Date Received07 21 2022 Decision Date08 09 2022 Product Code Nek Advisory Committee Orthopedic Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Medtronic Sofamor Danek Usa Inc 1800 Pyramid Placememphis Tn 38132 Pma Numberp000058 Supplement Numbers087 Date Received07 21 2022 Decision Date08 09 2022 Product Code Nek Advisory Committee Orthopedic Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier 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 P000058S087 Medtronic Sofamor Danek USA, Inc.1800 Pyramid Placememphis, TN 38132 PMA NumberP000058 Supplement NumberS087 Date Received07/21/2022 Decision Date08/09/2022 Product Code NEK  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Infuse™ Bone Graft/Medtronic Interbody Fusion	2022-08-09