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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 K232140
Device Name OTS Hip
Applicant
Ortoma AB
Falkenbergsgatan 3
Gothenburg,  SE 412 85
Applicant Contact Linus Byström
Correspondent
Hogan Lovells, LLC
Columbia Square, 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/18/2023
Decision Date 03/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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