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

Clearance record K142413

TITAN Modular Total Shoulder System · Ascension Orthopedics · decided 2014-11-14 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Titan™ Total Shoulder SystemGLN092003002PAscension Orthopedics, Inc.HSD KWS10381780120209
Titan™ Modular Total Shoulder SystemTSS1IMPAscension Orthopedics, Inc.HSD KWS10381780125686
Titan™ Total Shoulder SystemMHH-0923-010-4416CAscension Orthopedics, Inc.HSD KWS10381780123309
Titan Modular Shoulder System 2.5MHH-0923-010-4216ESmith & Nephew, Inc.HSD KWS00885556861189
Titan™ Total Shoulder SystemSEM092002506Ascension Orthopedics, Inc.HSD KWS10381780120490
Titan™ Total Shoulder SystemGLN092003000KAscension Orthopedics, Inc.HSD KWS10381780120155
Titan™ Total Shoulder SystemGLN092003002KAscension Orthopedics, Inc.HSD KWS10381780120193
Titan™ Total Shoulder SystemGLN092003001KAscension Orthopedics, Inc.HSD KWS10381780120179
Titan Modular Shoulder System 2.5BOD-0923-020-10LRGSmith & Nephew, Inc.HSD KWS00885556859407
Titan™ Total Shoulder SystemMHH-0923-010-4216EAscension Orthopedics, Inc.HSD KWS10381780123293
Titan™ Total Shoulder SystemM9200104419EAscension Orthopedics, Inc.HSD KWS10381780120308
Titan™ Total Shoulder SystemM9200104815EAscension Orthopedics, Inc.HSD KWS10381780120384
Titan Modular Shoulder System 2.5STEM-0920-025-06Smith & Nephew, Inc.HSD KWS00885556862049
Titan™ Total Shoulder SystemSEM095002510Ascension Orthopedics, Inc.HSD KWS10381780120629
Titan Modular Shoulder System 2.5MHH-0923-010-4620ESmith & Nephew, Inc.HSD KWS00885556861288
Titan Modular Shoulder System 2.5BSW-0920-021-01Smith & Nephew, Inc.HSD KWS00885556859537
Titan™ Total Shoulder SystemMHH-0923-010-4614EAscension Orthopedics, Inc.HSD KWS10381780123354
Titan Modular Shoulder System 2.5STEM-0920-025-07Smith & Nephew, Inc.HSD KWS00885556862056
Titan™ Total Shoulder SystemM9200104216EAscension Orthopedics, Inc.HSD KWS10381780120261
Titan™ Total Shoulder SystemB92002008STDAscension Orthopedics, Inc.HSD KWS10381780123071
Titan Modular Shoulder System 2.5GLN-0920-030-00KSmith & Nephew, Inc.HSD KWS00885556860342
Titan™ Total Shoulder SystemMHH-0923-010-4620CAscension Orthopedics, Inc.HSD KWS10381780123385
Titan™ Total Shoulder SystemMHH-0923-010-5220CAscension Orthopedics, Inc.HSD KWS10381780123507
Titan™ Total Shoulder SystemMHH-0923-010-4821CAscension Orthopedics, Inc.HSD KWS10381780123446
Titan Modular Shoulder System 2.5GLN-0920-030-00PSmith & Nephew, Inc.HSD KWS00885556860359