PMA P120024S014

Device: activL Artificial Disc
Applicant: Highridge Medical, LLC
PMA number: P120024
Supplement: S014
Product code: MJO
Decision date: 2026-01-29
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval of the Olive Branch Distribution Center (FEI 3016050940) as an additional facility for conducting incoming product inspections, Device History Record (DHR) documentation review, and release of finished goods into inventory for distribution of the subject device to the United States market.

Current openFDA PMA Record#

Device: activL Artificial Disc
Applicant: Highridge Medical, LLC
PMA number: P120024
Supplement: S014
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-01-29
Decision code: APPR
Date received: 2025-10-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the Olive Branch Distribution Center (FEI 3016050940) as an additional facility for conducting incoming product inspections, Device History Record (DHR) documentation review, and release of finished goods into inventory for distribution of the subject device to the United States market.