FDA 510(k)

Tornier Perform Reversed Glenoid et Tornier Perform Reversed Augmented Glenoid Shoulder System

Numéro K : K260102 · 2026-06-12

DemandeurStryker Corporation (Tornier, Inc.)

Date de décision2026-06-12

Code produitPHX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K260102. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System?

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K260102.

When did Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System receive FDA 510(k) clearance?

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System received FDA 510(k) clearance on 2026-06-12, under 510(k) number K260102.

Who is the listed applicant for Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System?

The FDA 510(k) record lists Stryker Corporation (Tornier, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System?

The FDA product code for Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System is PHX.

Essais cliniques associés

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Autres dossiers indiquant Stryker Corporation (Tornier, Inc.) en tant que demandeur

K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)K241609Tornier Humeral Reconstruction System (Tornier HRS)

Dispositifs connexes (Code : PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics K260583Equinoxe® Shoulder SystemExactech, Inc.

Source officielle

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