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FDA 510(k)

Metal Bone Screw

K-Number: K220921 · 2022-12-12

ApplicantDouble Medical Technology, Inc.
Decision Date2022-12-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Metal Bone Screw is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-12-12 under 510(k) number K220921. 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 Metal Bone Screw?

Metal Bone Screw is a medical device that received FDA 510(k) clearance on 2022-12-12. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K220921.

When did Metal Bone Screw receive FDA 510(k) clearance?

Metal Bone Screw received FDA 510(k) clearance on 2022-12-12, under 510(k) number K220921.

Who is the listed applicant for Metal Bone Screw?

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

What is the FDA product code for Metal Bone Screw?

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

Related Clinical Trials

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.

NCT02918734Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference ScrewsRECRUITINGNCT05662449A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle FractureCOMPLETEDNCT07693933Biodegradable Magnesium Screws for Unstable Ankle Fracture SurgeryNOT_YET_RECRUITING

Other records listing Double Medical Technology, 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.

K252729Universal Spinal SystemK242348Locking Screw,CoCrMoK233078Posterior Cervical Spine SystemK223753Cervical Plate SystemK221150Advanced Bone PlateK221088Anatomic Bone Plate

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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.

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

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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