PMA P910066S005

Device: ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S005
Product code: LOF
Decision date: 1997-05-09
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: APPROVAL FOR THE USE OF IN VITRO, AND IN VIVO DATA FROM STUDIES INVESTIGATING THE BIOLOGICAL EFFECTS OF COMBINED MAGNETIC FIELDS ON BONE HEALING AT THE CELLULAR LEVEL.

Current openFDA PMA Record#

Device: ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Applicant: Djo, LLC
PMA number: P910066
Supplement: S005
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1997-05-09
Decision code: APPR
Date received: 1997-02-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE USE OF IN VITRO, AND IN VIVO DATA FROM STUDIES INVESTIGATING THE BIOLOGICAL EFFECTS OF COMBINED MAGNETIC FIELDS ON BONE HEALING AT THE CELLULAR LEVEL.