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FDA 510(k)

DynaNail TTC Fusion System

K-Number: K171376 · 2017-11-02

ApplicantMedShape, Inc.
Decision Date2017-11-02
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DynaNail TTC Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2017-11-02 under 510(k) number K171376. 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 DynaNail TTC Fusion System?

DynaNail TTC Fusion System is a medical device that received FDA 510(k) clearance on 2017-11-02. The listed applicant is MedShape, Inc.. The 510(k) number is K171376.

When did DynaNail TTC Fusion System receive FDA 510(k) clearance?

DynaNail TTC Fusion System received FDA 510(k) clearance on 2017-11-02, under 510(k) number K171376.

Who is the listed applicant for DynaNail TTC Fusion System?

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

What is the FDA product code for DynaNail TTC Fusion System?

The FDA product code for DynaNail TTC Fusion System is HSB.

Other records listing MedShape, 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.

K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroK250628DynaNail TTC Fusion SystemK240530DynaNail Mini Tapered HybridK220812DynaClip® Bone StapleK203595DynaFuse Fixation SystemK203381Dynanail Mini Hybrid

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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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