Bone Growth Stimulators
FDA premarket approval P910066/S030 · decided 2019-08-02
Approval details
- PMA number
- P910066
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bone Growth Stimulators
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Djo, LLC
- Date received
- 2019-07-03
- Decision date
- 2019-08-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Vista, CA
- Statement
- Proposing a process change which introduces an upgraded version of the Automated Calibration System (ACS) for the SpinaLogic, OL1000 Dual Coil, and OL1000 Single Coil (SC) (sizes 1, 2, 3, 4) Bone Growth Stimulator devices.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |