ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Device Facts
| Record ID | P910066S011 |
|---|---|
| Device Name | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
| Applicant | Djo, LLC |
| Product Code | LOF · Orthopedic |
| Decision Date | Dec 17, 1999 |
| Decision | APPR |
| Regulation | 21 CFR 890.5870 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A non-invasive bone growth stimulator is a prescription device that provides stimulation through electrical, magnetic, or ultrasonic fields. The device is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation and spinal fusion or as a treatment for established nonunions or failed fusions. Please reference: www.federalregister.gov/documents/2026/04/16/2026-07366/physical-medicine-devices-reclassification-of-non-invasive-bone-growth-stimulators.
