FDA 510(k)

DynaClip Bone Staple

K-Number: K193305 · 2020-04-23

Decision Date2020-04-23

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DynaClip Bone Staple is a medical device manufactured by MedShape, Inc.. It received FDA 510(k) clearance on 2020-04-23 under approval number K193305. 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 DynaClip Bone Staple?

DynaClip Bone Staple is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by MedShape, Inc.. The 510(k) number is K193305.

When was DynaClip Bone Staple approved by the FDA?

DynaClip Bone Staple received FDA 510(k) clearance on 2020-04-23, under approval number K193305.

What company makes DynaClip Bone Staple?

DynaClip Bone Staple is manufactured by MedShape, Inc..

What is the FDA product code for DynaClip Bone Staple?

The FDA product code for DynaClip Bone Staple is JDR.

Other Devices by MedShape, Inc.

K171376DynaNail TTC Fusion System K181781DynaClipTM Bone Staple K182677DynaNail Mini 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.