PMA P850007S022

Device: PHYSIO-STIM BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S022
Product code: LOF
Decision date: 1998-08-13
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for a modification to the definition of non-union in the labeling (i.e., a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).

Current openFDA PMA Record#

Device: PHYSIO-STIM BONE GROWTH STIMULATOR
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S022
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1998-08-13
Decision code: APPR
Date received: 1998-06-24
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a modification to the definition of non-union in the labeling (i.e., a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).