- Device
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- Applicant
- Djo, LLC
- PMA number
- P910066
- Supplement
- S008
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 1998-06-12
- Decision code
- APPR
- Date received
- 1997-12-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the indications for use language to state "The Orthologic 1000 Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site show no visibly progressive sign s of healing"; and "The Orthologic CC Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauam, ecxluding vertebrae and all flate bones. A nonunion is considred to be established when the fracture site shows no visibly progressive signs of healing."