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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 K232176
Device Name STELLAR Knee
Applicant
PolarisAR Inc.
78 SW 7th Street
Suite 500
Miami,  FL  33130
Applicant Contact Paul Mikus
Correspondent
MEDIcept, Inc.
200 Homer Avenue
Ashland,  MA  01721
Correspondent Contact Richelle Helman
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/21/2023
Decision Date 11/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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