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FDA 510(k)

RetroFix

K-Number: K200226 · 2020-06-26

ApplicantRetrofix Screws, LLC
Decision Date2020-06-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RetroFix is the device name listed in this FDA 510(k) record. The listed applicant is Retrofix Screws, LLC. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200226. 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 RetroFix?

RetroFix is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Retrofix Screws, LLC. The 510(k) number is K200226.

When did RetroFix receive FDA 510(k) clearance?

RetroFix received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200226.

Who is the listed applicant for RetroFix?

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

What is the FDA product code for RetroFix?

The FDA product code for RetroFix is HWC. This falls under the Cardiovascular category.

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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