PMA P850007S028

Device: PHYSIO-STIM & SPINAL-STIM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S028
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 PHYSIO-STIM AND SPINAL-STIM. THE PHYSIO-SLIM IS INDICATED FOR THETREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALLFLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED LO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLYPROGRESSIVE SIGNS OF HEALING. THE SPINAL-SLIM IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASETHE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.

Current openFDA PMA Record#

Device: PHYSIO-STIM & SPINAL-STIM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S028
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 PHYSIO-STIM AND SPINAL-STIM. THE PHYSIO-SLIM IS INDICATED FOR THETREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALLFLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED LO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLYPROGRESSIVE SIGNS OF HEALING. THE SPINAL-SLIM IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASETHE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.