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FDA 510(k)

IRENE Cannulated Screw System

K-Number: K170056 · 2017-10-23

ApplicantTianjin Zhengtian Medical Instrument Co., Ltd.
Decision Date2017-10-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRENE Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K170056. 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 IRENE Cannulated Screw System?

IRENE Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K170056.

When did IRENE Cannulated Screw System receive FDA 510(k) clearance?

IRENE Cannulated Screw System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K170056.

Who is the listed applicant for IRENE Cannulated Screw System?

The FDA 510(k) record lists Tianjin Zhengtian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRENE Cannulated Screw System?

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

Other records listing Tianjin Zhengtian Medical Instrument 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.

K172267IRENE Thoracolumbar Fixation SystemK151508IRENE Locking Compression 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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