Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy
Device Facts
| Record ID | P850022 |
|---|---|
| Device Name | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy |
| Applicant | Ahp Eos Buyer, Inc. |
| Product Code | LOF · Orthopedic |
| Decision Date | Feb 18, 1986 |
| Decision | APRL |
| 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.
