FDA.reportPublic FDA data

PMA P850007S043

Device
PhysioStim and SpinalStim
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S043
Product code
LOF
Decision date
2019-10-08
Classification
Stimulator, Bone Growth, Non-invasive
Generic name
Stimulator, bone growth, non-invasive
Approval order statement
Modify the manufacturing process for sewing the garment assembly for the Orthofix SpinalStim Model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the Orthofix CervicalStim Model 5505 and Orthofix PhysioStim Models 53XX.

Current openFDA PMA Record#

Device
PhysioStim and SpinalStim
Applicant
Orthofix, Inc.
PMA number
P850007
Supplement
S043
Product code
LOF
Generic name
Stimulator, bone growth, non-invasive
Decision date
2019-10-08
Decision code
OK30
Date received
2019-09-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modify the manufacturing process for sewing the garment assembly for the Orthofix SpinalStim Model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the Orthofix CervicalStim Model 5505 and Orthofix PhysioStim Models 53XX.