FDA 510(k)

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

K-Nummer: K242442 · 2025-01-31

AntragstellerInnovate Orthopaedics, Ltd.

Entscheidungsdatum2025-01-31

ProduktcodeHWC

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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, Ltd.. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K242442. 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.

Häufig gestellte Fragen

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 2025-01-31. The listed applicant is Innovate Orthopaedics, Ltd.. The 510(k) number is K242442.

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 2025-01-31, under 510(k) number K242442.

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

The FDA 510(k) record lists Innovate Orthopaedics, Ltd. 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.

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Verwandte Geräte (Code: HWC)

K262975Arthrex Beaming-SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

Offizielle Quelle

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