Ebi Llc1 Gatehall Drivesuite 303parsippany Nj 07054 Pma Numberp790002 Supplement Numbers038 Date Received10 28 2022 Decision Date11 23 2022 Product Code Lof 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 Numberp790002 Supplement Numbers038 Date Received10 28 2022 Decision Date11 23 2022 Product Code Lof 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 P790002S038 EBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP790002 Supplement NumberS038 Date Received10/28/2022 Decision Date11/23/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Biomet® OrthoPak Non-invasive Bone Growth Stimulator System	2022-11-23