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FDA 510(k)

LTJ Screws and Washer

K-Number: K200987 · 2020-09-22

ApplicantAzurmeds, Inc.
Decision Date2020-09-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LTJ Screws and Washer is the device name listed in this FDA 510(k) record. The listed applicant is Azurmeds, Inc.. It received FDA 510(k) clearance on 2020-09-22 under 510(k) number K200987. 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 LTJ Screws and Washer?

LTJ Screws and Washer is a medical device that received FDA 510(k) clearance on 2020-09-22. The listed applicant is Azurmeds, Inc.. The 510(k) number is K200987.

When did LTJ Screws and Washer receive FDA 510(k) clearance?

LTJ Screws and Washer received FDA 510(k) clearance on 2020-09-22, under 510(k) number K200987.

Who is the listed applicant for LTJ Screws and Washer?

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

What is the FDA product code for LTJ Screws and Washer?

The FDA product code for LTJ Screws and Washer is HWC. This falls under the Cardiovascular category.

Other records listing Azurmeds, 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.

K210268LTJ Screws and Washer

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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