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FDA 510(k)

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00

K-Number: K014154 · 2002-03-18

ApplicantVilex, Inc.
Decision Date2002-03-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, Inc.. It received FDA 510(k) clearance on 2002-03-18 under 510(k) number K014154. 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 VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00?

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 is a medical device that received FDA 510(k) clearance on 2002-03-18. The listed applicant is Vilex, Inc.. The 510(k) number is K014154.

When did VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 receive FDA 510(k) clearance?

VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 received FDA 510(k) clearance on 2002-03-18, under 510(k) number K014154.

Who is the listed applicant for VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00?

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/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00?

The FDA product code for VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 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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