PMA P910066S025

Device: SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S025
Product code: LOF
Decision date: 2008-12-24
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR UPGRADES TO THE OL1000 SINGLE COIL, SIZE 1 MODEL AND THE MICROPROCESSOR-CONTROLLER (CONTROL BOX) USED FOR THE OL1000 SINGLE COIL, SIZE 1 MODEL.

Current openFDA PMA Record#

Device: SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S025
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2008-12-24
Decision code: APPR
Date received: 2008-06-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR UPGRADES TO THE OL1000 SINGLE COIL, SIZE 1 MODEL AND THE MICROPROCESSOR-CONTROLLER (CONTROL BOX) USED FOR THE OL1000 SINGLE COIL, SIZE 1 MODEL.