PMA P030034S002

Device: CERVICAL STIM
Applicant: Orthofix, Inc.
PMA number: P030034
Supplement: S002
Product code: LOF
Decision date: 2009-07-10
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM CERVICAL FUSION SYSTEM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.

Current openFDA PMA Record#

Device: CERVICAL STIM
Applicant: Orthofix, Inc.
PMA number: P030034
Supplement: S002
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2009-07-10
Decision code: APPR
Date received: 2009-05-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE RELOCATION AND CHANGE OF THE CHARGE MANAGEMENT CONTROLLER AND THE REPLACEMENT OF THE CHARGER UNIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM CERVICAL FUSION SYSTEM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSION.