Spinalogic Bone Growth Stimulator— 510(k) K262721
Substantially EquivalentDjo, LLC
FDA 510(k) clearance K262721 for Spinalogic Bone Growth Stimulator, Substantially Equivalent on 2026-09-29. Applicant: Djo, LLC. Device class: 2.
Summary
The Spinalogic Bone Growth Stimulator is filed under LOF, non-invasive bone growth stimulators. Non-invasive means the stimulator works from outside the body rather than being implanted. The record doesn't describe the stimulation method or the indication.
Class II, 21 CFR 890.5870. The Orthopedic panel reviewed it as a Traditional 510(k).
Djo, LLC filed from Carlsbad, California. Review took 60 days (July 31 to September 29, 2026).
Clearance details
- Applicant
- Djo, LLC
- Product code
- Product code LOF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5870
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code LOF
view allMore clearances from Djo, LLC
view allAdverse events under product code LOF
product code LOF- Death
- 3
- Injury
- 1,058
- Total
- 1,061
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.