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)

InCore® Lapidus Sterile Kits

K-Number: K190231 · 2019-05-24

ApplicantNextremity Solutions, Inc.
Decision Date2019-05-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

InCore® Lapidus Sterile Kits is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2019-05-24 under approval number K190231. 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 InCore® Lapidus Sterile Kits?

InCore® Lapidus Sterile Kits is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K190231.

When was InCore® Lapidus Sterile Kits approved by the FDA?

InCore® Lapidus Sterile Kits received FDA 510(k) clearance on 2019-05-24, under approval number K190231.

What company makes InCore® Lapidus Sterile Kits?

InCore® Lapidus Sterile Kits is manufactured by Nextremity Solutions, Inc..

What is the FDA product code for InCore® Lapidus Sterile Kits?

The FDA product code for InCore® Lapidus Sterile Kits is HWC. This falls under the Cardiovascular category.

Other Devices by Nextremity Solutions, Inc.

K182201Stratum™ Foot Plating System K180257InCore® Lapidus System K192578InCore TMT System K200785Stratum™ Reduced Size Foot Plating System K200840DuoHex CH Cannulated Hammertoe 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.

↑