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

Clearance record K152047

INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid · Ascension Orthopedics · decided 2015-12-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TITAN™GLN-0926-030-02AAscension Orthopedics, Inc.KWS10381780258698
Titan Modular Shoulder System 2.5GLN-0926-030-02ASmith & Nephew, Inc.KWS00885556860328
TITAN™GLN-0926-030-03AAscension Orthopedics, Inc.KWS10381780258704
Titan Modular Shoulder System 2.5GLN-0926-030-01ASmith & Nephew, Inc.KWS00885556860311
Titan Modular Shoulder System 2.5GLN-0926-030-00ASmith & Nephew, Inc.KWS00885556860304
TITAN™GLN-0926-030-00AAscension Orthopedics, Inc.KWS10381780258674
TITAN™GLN-0926-030-01AAscension Orthopedics, Inc.KWS10381780258681
Titan Modular Shoulder System 2.5GLN-0926-030-03ASmith & Nephew, Inc.KWS00885556860335