PMA P850007S018

Device: PHYSIO-STIM LITE BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S018
Product code: LOF
Decision date: 1997-04-16
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DESIGN AND LABELING OF THE PHYSIO-STIM(R) BONE GROWTH STIMULATOR. THE DEVICE, AS MODIFIED, IS TO BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM(R) LITE AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING BERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE INJURY AND THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HELAING FOR A MINIMUM OF THREE MONTHS (NO CHANGE IN THE FRACTURE CALLUS)

Current openFDA PMA Record#

Device: PHYSIO-STIM LITE BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S018
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1997-04-16
Decision code: APPR
Date received: 1996-05-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DESIGN AND LABELING OF THE PHYSIO-STIM(R) BONE GROWTH STIMULATOR. THE DEVICE, AS MODIFIED, IS TO BE MARKETED UNDER THE TRADE NAME PHYSIO-STIM(R) LITE AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING BERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE INJURY AND THE FRACTURE SITE SHOWS NO VISIBLY PROGRESSIVE SIGNS OF HELAING FOR A MINIMUM OF THREE MONTHS (NO CHANGE IN THE FRACTURE CALLUS)