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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K261852
Device Name OTS Hip
Applicant
Ortoma AB
Falkenbergsgatan 3
Gothenburg,  SE 41285
Applicant Contact Fredrik Strömberg
Correspondent
Hogan Lovells US Llp
Columbia Sq.
555 Thirteenth St., NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/03/2026
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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