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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name intra-articular orthopedic stereotaxic navigation instrument
De Novo Number DEN250037
Device Name TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
Requester
smith & nephew, inc.
150 minuteman rd.
andover,  MA  01810
Contact pooja dalvi
Regulation Number888.4561
Classification Product Code
SIQ  
Date Received08/22/2025
Decision Date 07/06/2026
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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