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FDA 510(k)

PERFORM Humeral System – Stem

K-Number: K201315 · 2020-09-11

ApplicantTornier, Inc.
Decision Date2020-09-11
Product CodePAO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFORM Humeral System – Stem is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K201315. The device is classified under product code PAO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFORM Humeral System – Stem?

PERFORM Humeral System – Stem is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Tornier, Inc.. The 510(k) number is K201315.

When did PERFORM Humeral System – Stem receive FDA 510(k) clearance?

PERFORM Humeral System – Stem received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201315.

Who is the listed applicant for PERFORM Humeral System – Stem?

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 PERFORM Humeral System – Stem?

The FDA product code for PERFORM Humeral System – Stem is PAO.

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_RECRUITING

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 NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – Stemless

View all 19 devices →

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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