FDA 510(k)

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

K-Nummer: K254110 · 2026-03-18

Entscheidungsdatum2026-03-18

ProduktcodeHWC

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Weitere Einträge mit MedShape, Inc. als Antragsteller

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

Alle 11 Geräte anzeigen →

Verwandte Geräte (Code: 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.

Offizielle Quelle

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