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

Clearance record K113012

PROMOS MODULAR SHOULDER SYSTEM · Smith & Nephew, Inc. · decided 2012-01-05 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
PROMOS75101982Smith & Nephew, Inc.KWS07611996127218
PROMOS75042186Smith & Nephew, Inc.HSD KWS07611996120554
PROMOS75042182Smith & Nephew, Inc.HSD KWS07611996120530
PROMOS75101981Smith & Nephew, Inc.KWS07611996127201
PROMOS75042180Smith & Nephew, Inc.HSD KWS07611996120523
PROMOS75042184Smith & Nephew, Inc.HSD KWS07611996120547
PROMOS75101980Smith & Nephew, Inc.KWS07611996127195
PROMOS75101983Smith & Nephew, Inc.KWS07611996127225