Ortho Pro L L C

FDA Filings

This page includes the latest FDA filings for Ortho Pro L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K102601 ORTHO-PRO LLC	ORTHOFLEX ROD	2011-01-14
PMN K094037 ORTHO-PRO LLC	TC PLATING SYSTEM	2010-03-10
PMN K042310 ORTHO-PRO LLC	ORTHO-PRO CANNULATED BONE SCREWS	2004-09-16
PMN K032682 ORTHO-PRO LLC	STS SCREW	2003-10-22

Similar & Related FDA Registered Companies

• Ortho Pro Dent LLC
• ORTHOPRO LLC
• Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP030026 Supplement NumberS037 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP090028 Supplement NumberS018 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ORTHO-CLINICAL DIAGNOSTICS100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Orthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 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
• 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