M6-C Artificial Cervical Disc

FDA Premarket Approval P170036 S012

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceM6-C Artificial Cervical Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSpinal 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
Date Received2022-10-17
Decision Date2022-11-01
PMAP170036
SupplementS012
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSpinal Kinetics LLC
501 Mercury Drive
sunnyvale, 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 Combination ProductNo Approval Order Statement  
an Additional Cervical Instron Tester EQ 0180 And Associated Bluehill Software To Increase Manufacturing Capacity

Supplemental Filings

Supplement NumberDateSupplement Type
P170036Original Filing
S012 2022-10-17 30-day Notice
S011 2022-06-09 30-day Notice
S010 2022-03-08 30-day Notice
S009 2021-09-29 30-day Notice
S008 2020-12-22 Normal 180 Day Track No User Fee
S007 2020-09-17 30-day Notice
S006 2020-09-11 Normal 180 Day Track No User Fee
S005 2020-02-05 30-day Notice
S004 2020-01-09 30-day Notice
S003 2019-08-15 30-day Notice
S002 2019-04-17 30-day Notice
S001

NIH GUDID Devices

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