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FDA 510(k)

CurvaFix IM System

K-Number: K222505 · 2022-10-27

ApplicantCurvafix, Inc.
Decision Date2022-10-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CurvaFix IM 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 2022-10-27 under 510(k) number K222505. 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 IM System?

CurvaFix IM System is a medical device that received FDA 510(k) clearance on 2022-10-27. The listed applicant is Curvafix, Inc.. The 510(k) number is K222505.

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

CurvaFix IM System received FDA 510(k) clearance on 2022-10-27, under 510(k) number K222505.

Who is the listed applicant for CurvaFix IM 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 IM System?

The FDA product code for CurvaFix IM 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.

K252019CurvaFix Low Profile 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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