Spinal Kinetics L L C

FDA Filings

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

FDA Registration(s)

• Registration Number: 3004987282
• FEI Number: 3004987282
• Name: SPINAL KINETICS LLC
• Owner & Operator: SPINAL KINETICS, INC.
• Contact Address: 501 Mercury Dr --; Sunnyvale CA 94085 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 501 Mercury Dr ; SUNNYVALE, CA 94085 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN K220861 Spinal Kinetics LLC	M6-C Artificial Cervical Disc Instruments AS	2022-06-02
PMA P170036S009 Spinal Kinetics LLC	M6-C Artificial Cervial Disc	2021-10-12
PMA P170036S008 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2021-08-06
PMA P170036S007 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2020-10-14
PMA P170036S006 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2020-10-08
PMA P170036S005 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2020-03-04
PMA P170036S004 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2020-01-31
PMA P170036S003 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2019-09-05
PMA P170036S002 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2019-05-10
LXH SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6 Surgical Instruments	2019-02-26
LXH SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6 Manual Surgical Instruments	2019-02-26
PMN P170036 | MJO SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6-C Surgical Instruments	2019-02-19
PMN P170036 | MJO SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6-C Artificial Cervical Disc	2019-02-19
PMA P170036 Spinal Kinetics LLC	M6-C Artificial Cervical Disc	2019-02-06
MJO SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6-L Artificial Lumbar Disc	2009-01-05
LXH SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6 Surgical Instruments	2005-01-25
LXH SPINAL KINETICS LLC [SPINAL KINETICS, INC.]	M6 Manual Surgical Instruments	2005-01-25

Similar & Related FDA Registered Companies

• 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