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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 arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system
De Novo Number DEN250040
Device Name SportSuite Vision Software
Requester
stryker endoscopy
5900 optical ct.
san jose,  CA  95138
Contact lucas dan
Regulation Number888.1150
Classification Product Code
SIT  
Date Received09/02/2025
Decision Date 07/17/2026
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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