FDA 510(k)

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro

Número K: K254110 · 2026-03-18

Data da decisão2026-03-18

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K254110. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro?

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is MedShape, Inc.. The 510(k) number is K254110.

When did DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro receive FDA 510(k) clearance?

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro received FDA 510(k) clearance on 2026-03-18, under 510(k) number K254110.

Who is the listed applicant for DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro?

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 Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro?

The FDA product code for DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro is HWC. This falls under the Cardiovascular category.

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Outros registros que listam MedShape, Inc. como candidato(a)

K260995DynaNail Helix® Fixation System K250628DynaNail TTC Fusion System K240530DynaNail Mini Tapered Hybrid K220812DynaClip® Bone Staple K203595DynaFuse Fixation System K203381Dynanail Mini Hybrid

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Dispositivos Relacionados (Código: HWC)

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

Fonte oficial

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