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FDA 510(k)

DynaClip® Bone Staple

K-Number: K220812 · 2022-08-19

ApplicantMedShape, Inc.
Decision Date2022-08-19
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 2022-08-19 under approval number K220812. 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 2022-08-19. It is manufactured by MedShape, Inc.. The 510(k) number is K220812.

When was DynaClip® Bone Staple approved by the FDA?

DynaClip® Bone Staple received FDA 510(k) clearance on 2022-08-19, under approval number K220812.

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 K193305DynaClip Bone Staple K203381Dynanail Mini Hybrid 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

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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