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
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

Device IDPMASupp
00812388030391 P170036 000
00812388030193 P170036 000
00812388030209 P170036 000
00812388030216 P170036 000
00812388030223 P170036 000
00812388030230 P170036 000
00812388030247 P170036 000
00812388030254 P170036 000
00812388030261 P170036 000
00812388030278 P170036 000
00812388030285 P170036 000
00812388030186 P170036 000
00812388030179 P170036 000
00812388030162 P170036 000
00812388030452 P170036 000
00812388030391 P170036 000
00812388030452 P170036 000
00812388030094 P170036 000
00812388030100 P170036 000
00812388030117 P170036 000
00812388030124 P170036 000
00812388030131 P170036 000
00812388030148 P170036 000
00812388030155 P170036 000
00812388030292 P170036 000
00812388030308 P170036 000
00812388030315 P170036 000
00812388030452 P170036 000
00812388030469 P170036 000
00812388030476 P170036 000
00812388030018 P170036 000
00812388030025 P170036 000
00812388030032 P170036 000
00812388030049 P170036 000
00812388030056 P170036 000
00812388030063 P170036 000
00812388030070 P170036 000
00812388030445 P170036 000
00812388030438 P170036 000
00812388030421 P170036 000
00812388030322 P170036 000
00812388030339 P170036 000
00812388030346 P170036 000
00812388030353 P170036 000
00812388030360 P170036 000
00812388030377 P170036 000
00812388030384 P170036 000
00812388030391 P170036 000
00812388030407 P170036 000
00812388030414 P170036 000
00812388030087 P170036 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.