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

Clearance record K113121

COMPREHENSIVE REVERSE SHOULDER · Biomet Manufacturing, Inc. · decided 2011-12-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Comprehensive Reverse ShoulderEP-115395Biomet Orthopedics, LLCKWS PAO PHX00880304543133
Comprehensive Reverse ShoulderEP-115394Biomet Orthopedics, LLCKWS PAO PHX00880304543188
Comprehensive Reverse ShoulderEP-115398Biomet Orthopedics, LLCKWS PAO PHX00880304543140
Comprehensive Reverse ShoulderEP-115396Biomet Orthopedics, LLCKWS PAO PHX00880304543164
Comprehensive Reverse ShoulderEP-115397Biomet Orthopedics, LLCKWS PAO PHX00880304543171
Comprehensive Reverse ShoulderEP-115393Biomet Orthopedics, LLCKWS PAO PHX00880304543157