SPINALOGIC 1000 BONE GROWTH STIMULATOR
FDA premarket approval P910066/S021 · decided 2005-07-19
Approval details
- PMA number
- P910066
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPINALOGIC 1000 BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2005-06-01
- Decision date
- 2005-07-19
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL FOR THE DESCRIBED COIL MODIFICATIONS INCLUDING GEOMETRIC CHANGES, TURN SCHEDULE CHANGES, AND MANUFACTURING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINALOGIC 1000 BONE GROWTH STIMULATOR AND IS INDICATED AS AN ADJUNCT ELECTRICAL TREATMENT TO PRIMARY LUMBAR SPINAL FUSION SURGERY FOR ONE OR TWO LEVELS.
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510(k) clearances by this applicant
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|---|---|---|
| Compex Sport Elite 3.0 (K201653) | Djo, LLC | 2020-11-27 |
| Compex Sport Elite (K170918) | Djo, LLC | 2017-06-20 |
| Compex Wireless USA (K170903) | Djo, LLC | 2017-06-19 |
| Strive (K153704) | Djo, LLC | 2016-06-03 |
| Chattanooga Revolution Wireless (K153696) | Djo, LLC | 2016-04-14 |
| VitalStim(R) Plus Electrotherapy System (K153224) | Djo, LLC | 2016-02-17 |
| Compex Wireless USA (K143551) | Djo, LLC | 2015-04-28 |
| VECTRA NEO CLINICAL THERAPY SYSTEM (K132284) | Djo, LLC | 2014-04-10 |