M6-C Artificial Cervical Disc

FDA Premarket Approval P170036 S004

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

To add a new cervical flexural resistance (cer-fr) tester, eq 0152-01

DeviceM6-C Artificial Cervical Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSpinal Kinetics LLC
Date Received2020-01-09
Decision Date2020-01-31
PMAP170036
SupplementS004
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
S004 2020-01-09 30-day Notice
S003 2019-08-15 30-day Notice
S002 2019-04-17 30-day Notice
S001

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