M6-C Artificial Cervical Disc

FDA Premarket Approval P170036 S006

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

Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170036.

DeviceM6-C Artificial Cervical Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSpinal Kinetics LLC
Date Received2020-09-11
Decision Date2020-10-08
PMAP170036
SupplementS006
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Spinal Kinetics LLC 501 Mercury Drive sunnyvale, CA 94085

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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