PMA P850007S035

Device: Spinal-Stim
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S035
Product code: LOF
Decision date: 2016-12-02
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Model 5505.

Current openFDA PMA Record#

Device: Spinal-Stim
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S035
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2016-12-02
Decision code: APPR
Date received: 2016-07-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Model 5505.