SPINALOGIC BONE GROWTH STIMULATOR
FDA premarket approval P910066/S015 · decided 2000-08-23
Approval details
- PMA number
- P910066
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPINALOGIC BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2000-03-31
- Decision date
- 2000-08-23
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- APPROVAL TO *REMOVE THE FOLLOWING PRECAUTION FROM THE SUMMARY OF SAFETY AND EFFECTIVENESS AND PROFESSIONAL LABELING; "THE SAFETY AND EFFECTIVENESS OF THE SPINALOGIC(R) HAS ONLY BEEN STUDIED IN PATIENTS HAVING SPINAL FUSION TREATMENT. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE IN PATIENTS RECEIVING INSTRUMENTATION, WHICH MAY DISTORT THE MAGNETIC FIELD GENERATED BY THE DEVICE AND THUS PRODUCE A LESS EFFECTIVE TREATMENT, HAS NOT BEEN ESTABLISHED"; AND *MODIFY THE FOLLOWING STATEMENT I NTHE RISKS A
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |