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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K112438

TITAN MODULAR TOTAL SHOULDER SYSTEM · Ascension Orthopedic · decided 2012-04-11 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Titan Modular Shoulder System 2.5STEM-0950-025-08Smith & Nephew, Inc.HSD KWS00885556837726
Titan Modular Shoulder SystemSTEM-0950-025-10125Smith & Nephew, Inc.HSD KWS00885556837672
Titan Modular Shoulder System 2.5STEM-0950-025-06Smith & Nephew, Inc.HSD KWS00885556837719
Titan Modular Shoulder System 2.5STEM-0950-025-10Smith & Nephew, Inc.HSD KWS00885556837733
Titan Modular Shoulder SystemSTEM-0950-025-10165Smith & Nephew, Inc.HSD KWS00885556837689
Titan Modular Shoulder System 2.5STEM-0950-025-14Smith & Nephew, Inc.HSD KWS00885556837757
Titan Modular Shoulder SystemSTEM-0950-025-08125Smith & Nephew, Inc.HSD KWS00885556837658
Titan Modular Shoulder SystemSTEM-0950-025-12165Smith & Nephew, Inc.HSD KWS00885556837702
Titan Modular Shoulder SystemSTEM-0950-025-08165Smith & Nephew, Inc.HSD KWS00885556837665
Titan Modular Shoulder SystemSTEM-0950-025-12125Smith & Nephew, Inc.HSD KWS00885556837696
Titan Modular Shoulder System 2.5STEM-0950-025-12Smith & Nephew, Inc.HSD KWS00885556837740