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

Clearance record K160975

Aequalis PerFORM+ Shoulder System · Tornier, Inc. · decided 2016-06-10 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Tornier Perform® Anatomic Augmented GlenoidDWK406RA35STORNIER, INC.KWS00846832091638
Tornier Perform® Anatomic Augmented GlenoidDWK404LA15STORNIER, INC.KWS00846832091553
Tornier Perform® Anatomic Augmented GlenoidDWK403RA25STORNIER, INC.KWS00846832091591
Tornier Perform® Anatomic Augmented GlenoidDWK403LA25STORNIER, INC.KWS00846832092048
Tornier Perform® Anatomic Augmented GlenoidDWK406RA25STORNIER, INC.KWS00846832091607
Tornier Perform® Anatomic Augmented GlenoidDWK406LA15STORNIER, INC.KWS00846832091720
Tornier Perform® Anatomic Augmented GlenoidDWK404RA35STORNIER, INC.KWS00846832091690
Tornier Perform® Anatomic Augmented GlenoidDWK404RA25STORNIER, INC.KWS00846832091584
Tornier Perform® Anatomic Augmented GlenoidDWK403RA15STORNIER, INC.KWS00846832091539
Tornier Perform® Anatomic Augmented GlenoidDWK405RA15STORNIER, INC.KWS00846832091645
Tornier Perform® Anatomic Augmented GlenoidDWK404LA25STORNIER, INC.KWS00846832091737
Tornier Perform® Anatomic Augmented GlenoidDWK406LA35STORNIER, INC.KWS00846832091911
Tornier Perform® Anatomic Augmented GlenoidDWK404LA35STORNIER, INC.KWS00846832091980
Tornier Perform® Anatomic Augmented GlenoidDWK405LA25STORNIER, INC.KWS00846832092062
Tornier Perform® Anatomic Augmented GlenoidDWK405LA35STORNIER, INC.KWS00846832091867
Tornier Perform® Anatomic Augmented GlenoidDWK405LA15STORNIER, INC.KWS00846832091997
Tornier Perform® Anatomic Augmented GlenoidDWK404RA15STORNIER, INC.KWS00846832091782
Tornier Perform® Anatomic Augmented GlenoidDWK405RA35STORNIER, INC.KWS00846832091829
Tornier Perform® Anatomic Augmented GlenoidDWK406RA15STORNIER, INC.KWS00846832091850
Tornier Perform® Anatomic Augmented GlenoidDWK405RA25STORNIER, INC.KWS00846832092024
Tornier Perform® Anatomic Augmented GlenoidDWK403RA35STORNIER, INC.KWS00846832091768
Tornier Perform® Anatomic Augmented GlenoidDWK406LA25STORNIER, INC.KWS00846832091799
Tornier Perform® Anatomic Augmented GlenoidDWK403LA35STORNIER, INC.KWS00846832091676
Tornier Perform® Anatomic Augmented GlenoidDWK403LA15STORNIER, INC.KWS00846832091805