FDA 510(k)

DynaClipTM Bone Staple

K-Number: K181781 · 2018-11-05

Decision Date2018-11-05

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DynaClipTM Bone Staple is a medical device manufactured by MedShape, Inc.. It received FDA 510(k) clearance on 2018-11-05 under approval number K181781. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaClipTM Bone Staple?

DynaClipTM Bone Staple is a medical device that received FDA 510(k) clearance on 2018-11-05. It is manufactured by MedShape, Inc.. The 510(k) number is K181781.

When was DynaClipTM Bone Staple approved by the FDA?

DynaClipTM Bone Staple received FDA 510(k) clearance on 2018-11-05, under approval number K181781.

What company makes DynaClipTM Bone Staple?

DynaClipTM Bone Staple is manufactured by MedShape, Inc..

What is the FDA product code for DynaClipTM Bone Staple?

The FDA product code for DynaClipTM Bone Staple is JDR.

Other Devices by MedShape, Inc.

K171376DynaNail TTC Fusion System K182677DynaNail Mini K193305DynaClip Bone Staple K203381Dynanail Mini Hybrid K220812DynaClip® Bone Staple K203595DynaFuse Fixation System

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Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.