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FDA 510(k)

Tornier Perform Humeral System – Fracture

K-Number: K220914 · 2022-10-14

ApplicantTornier, Inc.
Decision Date2022-10-14
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Perform Humeral System – Fracture is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K220914. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornier Perform Humeral System – Fracture?

Tornier Perform Humeral System – Fracture is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Tornier, Inc.. The 510(k) number is K220914.

When did Tornier Perform Humeral System – Fracture receive FDA 510(k) clearance?

Tornier Perform Humeral System – Fracture received FDA 510(k) clearance on 2022-10-14, under 510(k) number K220914.

Who is the listed applicant for Tornier Perform Humeral System – Fracture?

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

What is the FDA product code for Tornier Perform Humeral System – Fracture?

The FDA product code for Tornier Perform Humeral System – Fracture is PHX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05773352Perform® Humeral System - Fracture Study (PFX)ACTIVE_NOT_RECRUITINGNCT05500066Tornier HRS (Humeral Reconstruction System) Study (REVIVE)ENROLLING_BY_INVITATION

Other records listing Tornier, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidK252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220418Tornier Perform Humeral System – StemlessK211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

View all 19 devices →

Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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