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FDA 510(k)

VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)

K-Number: K112837 · 2012-10-09

ApplicantVilex, Inc.
Decision Date2012-10-09
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, Inc.. It received FDA 510(k) clearance on 2012-10-09 under 510(k) number K112837. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)?

VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) is a medical device that received FDA 510(k) clearance on 2012-10-09. The listed applicant is Vilex, Inc.. The 510(k) number is K112837.

When did VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) receive FDA 510(k) clearance?

VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) received FDA 510(k) clearance on 2012-10-09, under 510(k) number K112837.

Who is the listed applicant for VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)?

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 EZ-STAPLE (MEMORY BONE FIXATION STAPLE)?

The FDA product code for VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) is JDR.

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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.

K102413FUZE: INTRAMEDULLARY INTERNAL FIXATION NAILK102401HEMI IMPLANT; MINI HEMI IMPLANTK070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONK052196VILEX X-FIXK041289TALUS OF VILEX (TOV)K041287VILEX BONE PLATE SYSTEM

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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