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FDA 510(k)

Cannulated Fasteners and Nuts

K-Number: K210754 · 2021-04-14

ApplicantOsteoCentric Technologies
Decision Date2021-04-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Fasteners and 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 2021-04-14 under 510(k) number K210754. 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 Cannulated Fasteners and Nuts?

Cannulated Fasteners and Nuts is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is OsteoCentric Technologies. The 510(k) number is K210754.

When did Cannulated Fasteners and Nuts receive FDA 510(k) clearance?

Cannulated Fasteners and Nuts received FDA 510(k) clearance on 2021-04-14, under 510(k) number K210754.

Who is the listed applicant for Cannulated Fasteners and 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 Cannulated Fasteners and Nuts?

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

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.

K250520OsteoCentric Navigated Instruments SystemK251913OsteoCentric® UnifiMI® TCS Plating SystemK250494The OsteoCentric Bone Plate and Screw SystemK242691OsteoCentric Technologies Cannulated Fasteners and NutsK230242OsteoCentric Dental Implant SystemK230226Integrity-SI® Fusion 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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, 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.

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