FDA.reportPublic FDA data

PMA P910066S030

Device
Bone Growth Stimulators
Applicant
Djo, LLC
PMA number
P910066
Supplement
S030
Product code
LOF
Decision date
2019-08-02
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
Approval order statement
Proposing a process change which introduces an upgraded version of the Automated Calibration System (ACS) for the SpinaLogic, OL1000 Dual Coil, and OL1000 Single Coil (SC) (sizes 1, 2, 3, 4) Bone Growth Stimulator devices.

Current openFDA PMA Record#

Device
Bone Growth Stimulators
Applicant
Djo, LLC
PMA number
P910066
Supplement
S030
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2019-08-02
Decision code
OK30
Date received
2019-07-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Proposing a process change which introduces an upgraded version of the Automated Calibration System (ACS) for the SpinaLogic, OL1000 Dual Coil, and OL1000 Single Coil (SC) (sizes 1, 2, 3, 4) Bone Growth Stimulator devices.