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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Bone Growth, Non-Invasive
510(k) Number K262721
Device Name Spinalogic Bone Growth Stimulator
Applicant
Djo, LLC
5919 Sea Otter Pl.
Carlsbad,  CA  92010
Applicant Contact Mitchell Dhority
Correspondent
Hogan Lovells Cadwalader US LLP
555 Thirteenth St. NW
Washingon,  DC  20004
Correspondent Contact Kristin Duggan
Classification Product Code
LOF  
Date Received07/31/2026
Decision Date 09/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT05101057
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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