FDA.reportPublic FDA data

PMA P910066

Device
CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)
Applicant
Djo, LLC
PMA number
P910066
Supplement
S031
Product code
LOF
Decision date
2020-01-23
Generic name
Stimulator, bone growth, non-invasive
Approval order statement
Approval for design changes to the microcontroller and associated changes to the printed circuit board of the CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic).

Current openFDA PMA Record#

Device
CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)
Applicant
Djo, LLC
PMA number
P910066
Supplement
S031
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2020-01-23
Decision code
APPR
Date received
2019-10-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for design changes to the microcontroller and associated changes to the printed circuit board of the CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic).