ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
FDA premarket approval P910066/S005 · decided 1997-05-09
Approval details
- PMA number
- P910066
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 1997-02-26
- Decision date
- 1997-05-09
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- 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.
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