Zimmer

FDA Filings

This page includes the latest FDA filings for Zimmer. 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 K150730 ZIMMER	Zimmer PSI Shoulder System	2015-06-16

Similar & Related FDA Registered Companies

• Zimmer, Inc.
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• Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110002 Supplement NumberS034 Date Received11/08/2022 Decision Date11/28/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110009 Supplement NumberS034 Date Received11/08/2022 Decision Date11/28/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Zimmer Biomet Spine, Inc.10225 Westmoor Drivewestminster, CO 80021 PMA NumberP110009 Supplement NumberS032 Date Received01/21/2022 Decision Date11/09/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS082 Date Received09/30/2022 Decision Date10/06/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS080 Date Received07/25/2022 Decision Date08/15/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS079 Date Received05/09/2022 Decision Date05/20/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS078 Date Received03/07/2022 Decision Date03/23/2022 Product Code NJL  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ZIMMER BIOMET INC
• ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
• Zimmer Surgical SA
• ZIMMER TRABECULAR METAL TECHNOLOGY INC.
• Zimmer Us, Inc.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020040760729	Moin,Costa Rica -> Philadelphia, Pennsylvania	MEDICAL DEVICES	446 BOX
2018052817709	Stadersand,Federal Republic of Germany -> Los Angeles, California	SPARE PARTS AND ACCESSORIES FOR THERAPY DEVICES HS CODE 330499, 392330, 392690, 401699, 420219, 731819, 732690, 830220, 841430, 841459, 841950, 842129, 842199, 844399,	97 PCS