MySpine S2-SI Pedicle And Sacro-Iliac Screw Placement Guides

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

Medacta International S.A.

The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Myspine S2-si Pedicle And Sacro-iliac Screw Placement Guides.

Pre-market Notification Details

Device IDK220888
510k NumberK220888
Device Name:MySpine S2-SI Pedicle And Sacro-Iliac Screw Placement Guides
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant Medacta International S.A. Strada Regina Castel San Pietro,  CH CH-6874
ContactStefano Baj
CorrespondentChris Lussier
Medacta USA 3973 Delp Street Memphis,  TN  38118
Product CodeQSR
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-05-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630345752918 K220888 000
07630345752901 K220888 000
07630345752895 K220888 000
07630345752888 K220888 000
07630345752871 K220888 000
07630345752864 K220888 000

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