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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instruments designed for press-fit osteochondral implants
510(k) Number K192156
Device Name Cartiva SCI instrumentation set
Applicant
Cartiva, Inc.
6120 Windward Parkway, Suite 220
Alpharetta,  GA  30005
Applicant Contact Shriya Kafle
Correspondent
Cartiva, Inc.
6120 Windward Parkway, Suite 220
Alpharetta,  GA  30005
Correspondent Contact Shriya Kafle
Regulation Number888.4505
Classification Product Code
QBO  
Date Received08/09/2019
Decision Date 09/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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