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

Clearance record K131353

COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE · Biomet Manufacturing Corp · decided 2013-10-08 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Comprehensive Reverse ShoulderTI-115310Biomet Orthopedics, LLCKWS PAO PHX00880304687578
Comprehensive Reverse ShoulderTI-115320Biomet Orthopedics, LLCKWS PAO PHX00880304687608
Comprehensive Reverse ShoulderTI-115316Biomet Orthopedics, LLCKWS PAO PHX00880304687592
Comprehensive Reverse ShoulderTI-115323Biomet Orthopedics, LLCKWS PAO PHX00880304687615
Comprehensive Reverse ShoulderTI-115313Biomet Orthopedics, LLCKWS PAO PHX00880304687585
Comprehensive Reverse ShoulderTI-115326Biomet Orthopedics, LLCKWS PAO PHX00880304687622