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

Clearance record K212435

Comprehensive Humeral Fracture Positioning Sleeves · Biomet, Inc. · decided 2021-12-10 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Comprehensive® Shoulder System113585Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213159
Comprehensive® Shoulder System113583Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213135
Comprehensive® Shoulder System113579Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213098
Comprehensive® Shoulder System113576Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213067
Comprehensive® Shoulder System113577Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213074
Comprehensive® Shoulder System113584Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213142
Comprehensive® Shoulder System113575Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213050
Comprehensive® Shoulder System113574Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213043
Comprehensive® Shoulder System113582Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213128
Comprehensive® Shoulder System113580Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213104
Comprehensive® Shoulder System113581Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213111
Comprehensive® Shoulder System113578Biomet Orthopedics, LLCHSD KWS KWT MBF00880304213081