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FDA 510(k)

CurvaFix Low Profile System

K-Number: K252019 · 2025-08-29

ApplicantCurvafix, Inc.
Decision Date2025-08-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CurvaFix Low Profile System is the device name listed in this FDA 510(k) record. The listed applicant is Curvafix, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K252019. 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 CurvaFix Low Profile System?

CurvaFix Low Profile System is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Curvafix, Inc.. The 510(k) number is K252019.

When did CurvaFix Low Profile System receive FDA 510(k) clearance?

CurvaFix Low Profile System received FDA 510(k) clearance on 2025-08-29, under 510(k) number K252019.

Who is the listed applicant for CurvaFix Low Profile System?

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

What is the FDA product code for CurvaFix Low Profile System?

The FDA product code for CurvaFix Low Profile System is HWC. This falls under the Cardiovascular category.

Other records listing Curvafix, 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.

K222505CurvaFix IM SystemK180050CurvaFix Intramedullary Rodscrew 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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