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FDA 510(k)

Ntegrate Threaded Nail System

K-Number: K261961 · 2026-10-14

ApplicantNvision Biomedical Technologies
Decision Date2026-10-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ntegrate Threaded Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies. It received FDA 510(k) clearance on 2026-10-14 under 510(k) number K261961. 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 Ntegrate Threaded Nail System?

Ntegrate Threaded Nail System is a medical device that received FDA 510(k) clearance on 2026-10-14. The listed applicant is Nvision Biomedical Technologies. The 510(k) number is K261961.

When did Ntegrate Threaded Nail System receive FDA 510(k) clearance?

Ntegrate Threaded Nail System received FDA 510(k) clearance on 2026-10-14, under 510(k) number K261961.

Who is the listed applicant for Ntegrate Threaded Nail System?

The FDA 510(k) record lists Nvision Biomedical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ntegrate Threaded Nail System?

The FDA product code for Ntegrate Threaded Nail System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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.

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Other records listing Nvision Biomedical Technologies 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.

K262098EnHAnce PEEK Bunion SystemK250646Impact PEEK Union Nail SystemK242896Caliber Intramedullary Fixation SystemK243231Trigon PEEK HA WedgesK234116Trigon Trigon HA Stand-Alone Wedge Fixation System

Related Devices (Code: HWC)

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.

K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric TechnologiesK262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped

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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