Cartiva SCI Disposable Instrumentation Set

Instruments Designed For Press-fit Osteochondral Implants

Cartiva, Inc.

The following data is part of a premarket notification filed by Cartiva, Inc. with the FDA for Cartiva Sci Disposable Instrumentation Set.

Pre-market Notification Details

Device IDK181348
510k NumberK181348
Device Name:Cartiva SCI Disposable Instrumentation Set
ClassificationInstruments Designed For Press-fit Osteochondral Implants
Applicant Cartiva, Inc. 6120 Windward Parkway Suite 220 Alpharetta,  GA  30005
ContactTanya Eberle
CorrespondentTanya Eberle
Cartiva, Inc. 6120 Windward Parkway Suite 220 Alpharetta,  GA  30005
Product CodeQBO  
CFR Regulation Number888.4505 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-21
Decision Date2018-06-20
Summary:summary

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