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FDA 510(k)

DynaNail Mini

K-Number: K182677 · 2019-02-14

ApplicantMedShape, Inc.
Decision Date2019-02-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DynaNail Mini is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K182677. 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.

Frequently Asked Questions

What is the DynaNail Mini?

DynaNail Mini is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is MedShape, Inc.. The 510(k) number is K182677.

When did DynaNail Mini receive FDA 510(k) clearance?

DynaNail Mini received FDA 510(k) clearance on 2019-02-14, under 510(k) number K182677.

Who is the listed applicant for DynaNail Mini?

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?

The FDA product code for DynaNail Mini is HWC. This falls under the Cardiovascular category.

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: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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