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 ID: K220888
• 510k Number: K220888
• Device Name: MySpine S2-SI Pedicle And Sacro-Iliac Screw Placement Guides
• Classification: 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
• Applicant: Medacta International S.A. Strada Regina Castel San Pietro, CH CH-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: QSR
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-28
• Decision Date: 2022-05-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630345752918	K220888	000
07630345752901	K220888	000
07630345752895	K220888	000
07630345752888	K220888	000
07630345752871	K220888	000
07630345752864	K220888	000