M6-C Artificial Cervical Disc

FDA Premarket Approval P170036 S005

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 addition of a new belco tray sealer (eq 0048-02) to the m6-c production line

DeviceM6-C Artificial Cervical Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSpinal Kinetics LLC
Date Received2020-02-05
Decision Date2020-03-04
PMAP170036
SupplementS005
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Spinal Kinetics LLC 501 Mercury Drive sunnyvale, CA 94085

Supplemental Filings

Supplement NumberDateSupplement Type
P170036Original Filing
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
00812388030087 P170036 000
00812388030070 P170036 000
00812388030063 P170036 000
00812388030056 P170036 000
00812388030049 P170036 000
00812388030032 P170036 000
00812388030025 P170036 000
00812388030018 P170036 000

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