FDA 510(k)

Headless Compression Screw System

K-Nummer: K200259 · 2020-05-04

AntragstellerOsteocentric Extremities, LLC

Entscheidungsdatum2020-05-04

ProduktcodeHWC

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Headless Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Extremities, LLC. It received FDA 510(k) clearance on 2020-05-04 under 510(k) number K200259. 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 Headless Compression Screw System?

Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2020-05-04. The listed applicant is Osteocentric Extremities, LLC. The 510(k) number is K200259.

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

Headless Compression Screw System received FDA 510(k) clearance on 2020-05-04, under 510(k) number K200259.

Who is the listed applicant for Headless Compression Screw System?

The FDA 510(k) record lists Osteocentric Extremities, LLC as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Headless Compression Screw System 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.

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