Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DuoHex CH Cannulated Hammertoe System

K-Number: K200840 · 2020-06-26

ApplicantNextremity Solutions, Inc.
Decision Date2020-06-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DuoHex CH Cannulated Hammertoe System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K200840. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuoHex CH Cannulated Hammertoe System?

DuoHex CH Cannulated Hammertoe System is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K200840.

When was DuoHex CH Cannulated Hammertoe System approved by the FDA?

DuoHex CH Cannulated Hammertoe System received FDA 510(k) clearance on 2020-06-26, under approval number K200840.

What company makes DuoHex CH Cannulated Hammertoe System?

DuoHex CH Cannulated Hammertoe System is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for DuoHex CH Cannulated Hammertoe System?

The FDA product code for DuoHex CH Cannulated Hammertoe System is HWC. This falls under the Cardiovascular category.

Other Devices by Nextremity Solutions, Inc.

K182201Stratum™ Foot Plating System K180257InCore® Lapidus System K192578InCore TMT System K190231InCore® Lapidus Sterile Kits K200785Stratum™ Reduced Size Foot Plating System K200124InCore MPJ System

View all 14 devices →

Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, LLC

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.

↑