PMA P110009S009

Device: MOBI-C CERVICAL DISC PROSTHESIS
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S009
Product code: MJO
Decision date: 2015-02-05
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS.

Current openFDA PMA Record#

Device: MOBI-C CERVICAL DISC PROSTHESIS
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S009
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2015-02-05
Decision code: APPR
Date received: 2014-12-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS.