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

Clearance record K112983

SPACER-S · Tecres S.P.A. · decided 2011-12-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
InterSpace ShoulderSPS0021TECRES SPAHSD KWS28031497000392
InterSpace ShoulderSPS0121TECRES SPAHSD KWS28031497000408