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FDA 510(k)

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws

K-Number: K222967 · 2022-11-23

ApplicantAvanti Orthopaedics, Inc.
Decision Date2022-11-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws is the device name listed in this FDA 510(k) record. The listed applicant is Avanti Orthopaedics, Inc.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K222967. 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 Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws?

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Avanti Orthopaedics, Inc.. The 510(k) number is K222967.

When did Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws receive FDA 510(k) clearance?

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222967.

Who is the listed applicant for Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws?

The FDA 510(k) record lists Avanti Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws?

The FDA product code for Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws is HWC. This falls under the Cardiovascular category.

Other records listing Avanti Orthopaedics, Inc. 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.

K261145Avanti Distal Elbow ORIF SystemK211592Avanti Orthopaedics Ulnar Shortening SystemK191118Avanti Distal Radius and Forearm 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.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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