PMA P910066S021

Device: SPINALOGIC 1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S021
Product code: LOF
Decision date: 2005-07-19
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THE DESCRIBED COIL MODIFICATIONS INCLUDING GEOMETRIC CHANGES, TURN SCHEDULE CHANGES, AND MANUFACTURING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC 1000 BONE GROWTH STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.

Current openFDA PMA Record#

Device: SPINALOGIC 1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S021
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2005-07-19
Decision code: APPR
Date received: 2005-06-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE DESCRIBED COIL MODIFICATIONS INCLUDING GEOMETRIC CHANGES, TURN SCHEDULE CHANGES, AND MANUFACTURING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC 1000 BONE GROWTH STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.