PMA P120024S004

Device: ACTIVL ARTIFICIAL DISC
Applicant: Highridge Medical, LLC
PMA number: P120024
Supplement: S004
Product code: MJO
Decision date: 2017-06-20
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for labeling changes to the surgical technique and for the addition of the Class III activL® Slim Trial Instruments and the activL® Artificial Disc Ancillary Trialing & Confirmation instrument tray to the system

Current openFDA PMA Record#

Device: ACTIVL ARTIFICIAL DISC
Applicant: Highridge Medical, LLC
PMA number: P120024
Supplement: S004
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2017-06-20
Decision code: APPR
Date received: 2016-12-23
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling changes to the surgical technique and for the addition of the Class III activL® Slim Trial Instruments and the activL® Artificial Disc Ancillary Trialing & Confirmation instrument tray to the system