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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 a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2020-09-11 under approval 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. It is manufactured by Tornier, Inc.. The 510(k) number is K201315.

When was PERFORM Humeral System – Stem approved by the FDA?

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

What company makes PERFORM Humeral System – Stem?

PERFORM Humeral System – Stem is manufactured by Tornier, Inc..

What is the FDA product code for PERFORM Humeral System – Stem?

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

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Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Tornier, Inc.

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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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