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FDA 510(k)

dynaMX Tabbed Staple

K-Number: K153129 · 2016-01-28

ApplicantMx Orthopedics, Corp.
Decision Date2016-01-28
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

dynaMX Tabbed Staple is a medical device manufactured by Mx Orthopedics, Corp.. It received FDA 510(k) clearance on 2016-01-28 under approval number K153129. 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 dynaMX Tabbed Staple?

dynaMX Tabbed Staple is a medical device that received FDA 510(k) clearance on 2016-01-28. It is manufactured by Mx Orthopedics, Corp.. The 510(k) number is K153129.

When was dynaMX Tabbed Staple approved by the FDA?

dynaMX Tabbed Staple received FDA 510(k) clearance on 2016-01-28, under approval number K153129.

What company makes dynaMX Tabbed Staple?

dynaMX Tabbed Staple is manufactured by Mx Orthopedics, Corp..

What is the FDA product code for dynaMX Tabbed Staple?

The FDA product code for dynaMX Tabbed Staple is JDR.

Other Devices by Mx Orthopedics, Corp.

K160427dynaMX(TM) Nitinol Compression Screw K161303dynaMX™ Compression Plate

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 K172052Arthrex DynaNite Nitinol StapleArthrex, Inc.

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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