PMA P910066S023

Device: SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S023
Product code: LOF
Decision date: 2007-06-28
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE CONTROL BOX FOR THE OL1000, OL1000 SINGLE COIL (SIZE 2/3/4), AND SPINALOGIC DEVICES INCLUDING ENLARGED LCD ICON GRAPHICS AND PROMPTS, 9 VOLT ALKALINE BATTERY POWER SOURCE, AND UPDATED DEVICE SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS. THE OL1000 AND OL1000 SC DEVICES ARE INTENDED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES. THE SPINALOGIC DEVICE IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.

Current openFDA PMA Record#

Device: SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
Applicant: Djo, LLC
PMA number: P910066
Supplement: S023
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2007-06-28
Decision code: APPR
Date received: 2007-02-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE CONTROL BOX FOR THE OL1000, OL1000 SINGLE COIL (SIZE 2/3/4), AND SPINALOGIC DEVICES INCLUDING ENLARGED LCD ICON GRAPHICS AND PROMPTS, 9 VOLT ALKALINE BATTERY POWER SOURCE, AND UPDATED DEVICE SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS. THE OL1000 AND OL1000 SC DEVICES ARE INTENDED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES. THE SPINALOGIC DEVICE IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.