FDA 510(k)

BLUEPRINT Patient Specific Instrumentation

K-Number: K232265 · 2024-02-21

Decision Date2024-02-21

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BLUEPRINT Patient Specific Instrumentation is a medical device manufactured by Tornier S.A.S.. It received FDA 510(k) clearance on 2024-02-21 under approval number K232265. 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 BLUEPRINT Patient Specific Instrumentation?

BLUEPRINT Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2024-02-21. It is manufactured by Tornier S.A.S.. The 510(k) number is K232265.

When was BLUEPRINT Patient Specific Instrumentation approved by the FDA?

BLUEPRINT Patient Specific Instrumentation received FDA 510(k) clearance on 2024-02-21, under approval number K232265.

What company makes BLUEPRINT Patient Specific Instrumentation?

BLUEPRINT Patient Specific Instrumentation is manufactured by Tornier S.A.S..

What is the FDA product code for BLUEPRINT Patient Specific Instrumentation?

The FDA product code for BLUEPRINT Patient Specific Instrumentation is PHX.

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Related PubMed Literature

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Other Devices by Tornier S.A.S.

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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.