SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS
FDA premarket approval P910066/S023 · decided 2007-06-28
Approval details
- PMA number
- P910066
- Supplement
- S023
- Supplement type
- Real-Time Process
- 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
- 2007-02-05
- Decision date
- 2007-06-28
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE CONTROL BOX FOR THE OL1000, OL1000 SINGLE COIL (SIZE 2/3/4), AND SPINALOGIC DEVICES INCLUDING ENLARGED LCD ICON GRAPHICS AND PROMPTS, 9 VOLT ALKALINE BATTERY POWER SOURCE, AND UPDATED DEVICE SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS. THE OL1000 AND OL1000 SC DEVICES ARE INTENDED FOR THE NON-INVASIVE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA,
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