ORTHOLOGIC 1000 SC
FDA premarket approval P910066/S012 · decided 1998-10-16
Approval details
- PMA number
- P910066
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORTHOLOGIC 1000 SC
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 1998-09-22
- Decision date
- 1998-10-16
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- Modifications to the sizes of the device. The device, as modified, will be marketed under the trade name Orthologic 1000-SC and 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 shows no visibly progressive signs of healing.
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| Compex Wireless USA (K170903) | Djo, LLC | 2017-06-19 |
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| Chattanooga Revolution Wireless (K153696) | Djo, LLC | 2016-04-14 |
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| VECTRA NEO CLINICAL THERAPY SYSTEM (K132284) | Djo, LLC | 2014-04-10 |