PMA P030034S015

Device: CervicalStim
Applicant: Orthofix, Inc.
PMA number: P030034
Supplement: S015
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: CervicalStim
Applicant: Orthofix, Inc.
PMA number: P030034
Supplement: S015
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.