Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cannulated Screw and Kirschner (K wire) System

K-Number: K252758 · 2025-10-02

ApplicantOrthonovis, Inc.
Decision Date2025-10-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Screw and Kirschner (K wire) System is the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2025-10-02 under 510(k) number K252758. 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 Screw and Kirschner (K wire) System?

Cannulated Screw and Kirschner (K wire) System is a medical device that received FDA 510(k) clearance on 2025-10-02. The listed applicant is Orthonovis, Inc.. The 510(k) number is K252758.

When did Cannulated Screw and Kirschner (K wire) System receive FDA 510(k) clearance?

Cannulated Screw and Kirschner (K wire) System received FDA 510(k) clearance on 2025-10-02, under 510(k) number K252758.

Who is the listed applicant for Cannulated Screw and Kirschner (K wire) System?

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

What is the FDA product code for Cannulated Screw and Kirschner (K wire) System?

The FDA product code for Cannulated Screw and Kirschner (K wire) System is HWC. This falls under the Cardiovascular category.

Other records listing Orthonovis, 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.

K250498BPS Wrist Fracture SystemK250055BPS - Bone Fragment Fixation Plates, Screws and WashersK242343BPS Wrist Fracture SystemK213905ONX Large External 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.

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.

↑