Spin S P A

FDA Filings

This page includes the latest FDA filings for Spin S P A. 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
Iomeron BIPSO GmbH, BioChem Labor für biologishe und chemische Analytik GmbH, SPIN S.p.A.	Prescription Medication	2023-11-14
Iomeron BRACCO DIAGNOSTICS INC, BioChem Labor für biologishe und chemische Analytik GmbH, SPIN S.p.A., Patheon Italia S.p.A, BIPSO GmbH	Prescription Medication	2023-11-07
Iomeron BRACCO DIAGNOSTICS INC, BioChem Labor für biologishe und chemische Analytik GmbH, SPIN S.p.A., Patheon Italia S.p.A, BIPSO GmbH	Prescription Medication	2022-07-22
Iomeron BIPSO GmbH, BioChem Labor für biologishe und chemische Analytik GmbH, SPIN S.p.A.	Prescription Medication	2022-07-22

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• Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS012 Date Received10/17/2022 Decision Date11/01/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS011 Date Received06/09/2022 Decision Date07/01/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Spinal Kinetics LLC501 Mercury Drivesunnyvale, CA 94085 PMA NumberP170036 Supplement NumberS010 Date Received03/08/2022 Decision Date04/05/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIPSO GmbH
• BioChem Labor für biologishe und chemische Analytik GmbH
• BRACCO DIAGNOSTICS INC
• Patheon Italia S.p.A