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FDA 510(k)

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

K-Number: K231819 · 2023-09-05

ApplicantInnovate Orthopaedics Limited
Decision Date2023-09-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is the device name listed in this FDA 510(k) record. The listed applicant is Innovate Orthopaedics Limited. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K231819. 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 Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Innovate Orthopaedics Limited. The 510(k) number is K231819.

When did Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw receive FDA 510(k) clearance?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw received FDA 510(k) clearance on 2023-09-05, under 510(k) number K231819.

Who is the listed applicant for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

The FDA 510(k) record lists Innovate Orthopaedics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

The FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread 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.

NCT07511478Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle FracturesCOMPLETED

Other records listing Innovate Orthopaedics Limited 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.

K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewK212547Quick-Start Screws

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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