Depuy Orthopaedics

FDA Filings

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

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

• JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
• Karen Mahoney
• DEPUY INTL., LTD.
• Depuy Ireland UC

FDA Filings

Device Company	Device	Date
PMN K120599 DEPUY ORTHOPAEDICS	DEPUY M-SPEC 36MM FEMORAL HEADS	2013-04-30
PMN K123924 DEPUY ORTHOPAEDICS	DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS	2013-03-01

Similar & Related FDA Registered Companies

• DePuy Orthopaedics inc
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS103 Date Received11/28/2022 Decision Date12/08/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS102 Date Received09/07/2022 Decision Date10/04/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS101 Date Received07/28/2022 Decision Date08/26/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS100 Date Received07/01/2022 Decision Date07/12/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS098 Date Received05/09/2022 Decision Date06/07/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS097 Date Received04/07/2022 Decision Date05/05/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS094 Date Received02/22/2022 Decision Date03/22/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS093 Date Received02/14/2022 Decision Date03/10/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS091 Date Received02/11/2022 Decision Date02/22/2022 Product Code MRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No