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FDA 510(k)

SECURE Screw

K-Number: K191771 · 2019-10-16

ApplicantA.M. Surgical, Inc.
Decision Date2019-10-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SECURE Screw is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-16 under 510(k) number K191771. 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 SECURE Screw?

SECURE Screw is a medical device that received FDA 510(k) clearance on 2019-10-16. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K191771.

When did SECURE Screw receive FDA 510(k) clearance?

SECURE Screw received FDA 510(k) clearance on 2019-10-16, under 510(k) number K191771.

Who is the listed applicant for SECURE Screw?

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

What is the FDA product code for SECURE Screw?

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

Other records listing A.M. Surgical, 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.

K191345Pegasus SystemK180087A.M. Surgical Intramedullary Fixation Device

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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