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FDA 510(k)

GFS - Sterile Screws and Top Hat

K-Number: K253858 · 2026-08-05

ApplicantT.A.G. Medical Products Corporation, Ltd.
Decision Date2026-08-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GFS - Sterile Screws and Top Hat is the device name listed in this FDA 510(k) record. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K253858. 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 GFS - Sterile Screws and Top Hat?

GFS - Sterile Screws and Top Hat is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K253858.

When did GFS - Sterile Screws and Top Hat receive FDA 510(k) clearance?

GFS - Sterile Screws and Top Hat received FDA 510(k) clearance on 2026-08-05, under 510(k) number K253858.

Who is the listed applicant for GFS - Sterile Screws and Top Hat?

The FDA 510(k) record lists T.A.G. Medical Products Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GFS - Sterile Screws and Top Hat?

The FDA product code for GFS - Sterile Screws and Top Hat is HWC. This falls under the Cardiovascular category.

Other records listing T.A.G. Medical Products Corporation, Ltd. as applicant

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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.

K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLCK261241TriMed Compression ScrewsTriMed, Inc.K254215Arthrex Beaming SystemArthrex, Inc.

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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