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FDA 510(k)

Tandry Compression Screw System

K-Number: K220359 · 2022-09-20

ApplicantMicroware Precision Co., Ltd.
Decision Date2022-09-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tandry Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K220359. 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 Tandry Compression Screw System?

Tandry Compression Screw System is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K220359.

When did Tandry Compression Screw System receive FDA 510(k) clearance?

Tandry Compression Screw System received FDA 510(k) clearance on 2022-09-20, under 510(k) number K220359.

Who is the listed applicant for Tandry Compression Screw System?

The FDA 510(k) record lists Microware Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tandry Compression Screw System?

The FDA product code for Tandry Compression Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Microware Precision Co., Ltd. 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.

K242814Tandry Q-Locking Plate SystemK230690Tandry Locking Plate SystemK220360Tandry CMF Plate SystemK182929BIO-RAY A-1 Anchor Screw SystemK171904Tandry Locking Plate 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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