← Product Code [LOF](/productcode/LOF) · P910066S011

# ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066S011)

_Djo, LLC · LOF · Dec 17, 1999 · Orthopedic · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P910066S011

## Device Facts

- **Applicant:** Djo, LLC
- **Product Code:** [LOF](/productcode/LOF.md)
- **Decision Date:** Dec 17, 1999
- **Decision:** APPR
- **Regulation:** 21 CFR 890.5870
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/device/P910066S011](https://fda.innolitics.com/device/P910066S011)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com