Orthofix

FDA Filings

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

Orthofix holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• DAVID LENNARZ

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K130176 ORTHOFIX	FIREBIRD SPINAL FIXATION SYSTEM	2013-03-28
PMN K122901 ORTHOFIX	FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM	2012-12-03
PMN K121649 ORTHOFIX	CONSTRUX MINI PEEK TI SPACER SYSTEM	2012-11-29

Similar & Related FDA Registered Companies

• ORTHOFIX INC.
• ORTHOFIX SRL
• Orthofix US LLC
• 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
• Orthofix US LLC3451 Plano Parkwaylewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  Advisory Committee Orthopedic Expedited Review Granted? No