Ebi Llc1 Gatehall Drivesuite 303parsippany Nj 07054 Pma Numberp850035 Supplement Numbers058 Date Received10 28 2022 Decision Date11 23 2022 Product Code Loe 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 Ebi Llc1 Gatehall Drivesuite 303parsippany Nj 07054 Pma Numberp850035 Supplement Numbers058 Date Received10 28 2022 Decision Date11 23 2022 Product Code Loe 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 P850035S058 EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850035 Supplement NumberS058 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	SpF® Implantable Spinal Fusion Stimulators	2022-11-23