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FDA 510(k)

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

K-Number: K263116 · 2026-10-02

ApplicantOsteoCentric Technologies
Decision Date2026-10-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K263116. 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 OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts?

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is OsteoCentric Technologies. The 510(k) number is K263116.

When did OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts receive FDA 510(k) clearance?

OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts received FDA 510(k) clearance on 2026-10-02, under 510(k) number K263116.

Who is the listed applicant for OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts?

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

What is the FDA product code for OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts?

The FDA product code for OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts is HWC. This falls under the Cardiovascular category.

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Other records listing OsteoCentric 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.

K251913OsteoCentric® UnifiMI® TCS Plating SystemK250494The OsteoCentric Bone Plate and Screw SystemK242691OsteoCentric Technologies Cannulated Fasteners and NutsK230242OsteoCentric Dental Implant SystemK230226Integrity-SI® Fusion SystemK230595OsteoCentric ACL Fixation System

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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.

K262975Arthrex 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 OrthopedK262344Large Compression ScrewsTriMed, 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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