PMA P170036S008

Device: M6-C Artificial Cervical Disc
Applicant: Spinal Kinetics, LLC
PMA number: P170036
Supplement: S008
Product code: MJO
Decision date: 2021-08-06
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for Infinity Labs SD located at 1836 Stone Avenue, San Jose, California, 95125, for ethylene oxide sterilization of the M6-C Artificial Cervical Disc system.

Current openFDA PMA Record#

Device: M6-C Artificial Cervical Disc
Applicant: Spinal Kinetics, LLC
PMA number: P170036
Supplement: S008
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2021-08-06
Decision code: APPR
Date received: 2020-12-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for Infinity Labs SD located at 1836 Stone Avenue, San Jose, California, 95125, for ethylene oxide sterilization of the M6-C Artificial Cervical Disc system.