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FDA 510(k)

VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW

K-Number: K973309 · 1998-01-16

ApplicantVilex, Inc.
Decision Date1998-01-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, Inc.. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K973309. 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 for Some Indications.

Frequently Asked Questions

What is the VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW?

VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Vilex, Inc.. The 510(k) number is K973309.

When did VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW receive FDA 510(k) clearance?

VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW received FDA 510(k) clearance on 1998-01-16, under 510(k) number K973309.

Who is the listed applicant for VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW?

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

What is the FDA product code for VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW?

The FDA product code for VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Vilex, 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.

K112837VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILK102401HEMI IMPLANT; MINI HEMI IMPLANTK070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONK052196VILEX X-FIXK041287VILEX BONE PLATE SYSTEM

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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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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