SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
FDA premarket approval P910066/S025 · decided 2008-12-24
Approval details
- PMA number
- P910066
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2008-06-12
- Decision date
- 2008-12-24
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR UPGRADES TO THE OL1000 SINGLE COIL, SIZE 1 MODEL AND THE MICROPROCESSOR-CONTROLLER (CONTROL BOX) USED FOR THE OL1000 SINGLE COIL, SIZE 1 MODEL.
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