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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 the device name listed in this FDA 510(k) record. The listed applicant is Mx Orthopedics, Corp.. It received FDA 510(k) clearance on 2016-01-28 under 510(k) 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. The listed applicant is Mx Orthopedics, Corp.. The 510(k) number is K153129.

When did dynaMX Tabbed Staple receive FDA 510(k) clearance?

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

Who is the listed applicant for dynaMX Tabbed Staple?

The FDA 510(k) record lists Mx Orthopedics, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dynaMX Tabbed Staple?

The FDA product code for dynaMX Tabbed Staple is JDR.

Other records listing Mx Orthopedics, Corp. 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.

K161303dynaMX™ Compression PlateK160427dynaMX(TM) Nitinol Compression Screw

Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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