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FDA 510(k)

Tornier Humeral Nail and Tornier Long Humeral Nail

K-Number: K230352 · 2023-10-31

ApplicantTornier, Inc.
Decision Date2023-10-31
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Humeral Nail and Tornier Long Humeral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K230352. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornier Humeral Nail and Tornier Long Humeral Nail?

Tornier Humeral Nail and Tornier Long Humeral Nail is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Tornier, Inc.. The 510(k) number is K230352.

When did Tornier Humeral Nail and Tornier Long Humeral Nail receive FDA 510(k) clearance?

Tornier Humeral Nail and Tornier Long Humeral Nail received FDA 510(k) clearance on 2023-10-31, under 510(k) number K230352.

Who is the listed applicant for Tornier Humeral Nail and Tornier Long Humeral Nail?

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 Humeral Nail and Tornier Long Humeral Nail?

The FDA product code for Tornier Humeral Nail and Tornier Long Humeral Nail is HSB.

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.

NCT05500066Tornier HRS (Humeral Reconstruction System) Study (REVIVE)ENROLLING_BY_INVITATIONNCT05773352Perform® 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)K220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – StemlessK211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

View all 19 devices →

Related Devices (Code: HSB)

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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