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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 K181348
Device Name Cartiva SCI Disposable Instrumentation Set
Applicant
Cartiva, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta,  GA  30005
Applicant Contact Tanya Eberle
Correspondent
Cartiva, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta,  GA  30005
Correspondent Contact Tanya Eberle
Regulation Number888.4505
Classification Product Code
QBO  
Date Received05/21/2018
Decision Date 06/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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