Clearance Summary
Spinalogic Bone Growth Stimulator received FDA 510(k) clearance under submission number K262721, sponsored by Djo, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-09-29.
- Submission: K262721
- Applicant / Sponsor: Djo, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 890.5870
- Decision date: 2026-09-29
Classification & Regulation
This clearance is catalogued under FDA product code LOF and 21 CFR 890.5870, within the Orthopedic review panel as a Class II device.