PMA P110002S036

Device: LDR Spine Mobi-C Cervical Disc Prosthesis
Applicant: Highridge Medical, LLC
PMA number: P110002
Supplement: S036
Product code: MJO
Decision date: 2024-12-02
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: This supplement requested approval for extending shelf life of the LDR Spine Mobi-C® Cervical Disc Prosthesis from 5 years to 10 years.

Current openFDA PMA Record#

Device: LDR Spine Mobi-C Cervical Disc Prosthesis
Applicant: Highridge Medical, LLC
PMA number: P110002
Supplement: S036
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2024-12-02
Decision code: APPR
Date received: 2024-09-05
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: This supplement requested approval for extending shelf life of the LDR Spine Mobi-C® Cervical Disc Prosthesis from 5 years to 10 years.