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FDA 510(k)

HEMI IMPLANT; MINI HEMI IMPLANT

K-Number: K102401 · 2011-07-20

ApplicantVilex, Inc.
Decision Date2011-07-20
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMI IMPLANT; MINI HEMI IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, Inc.. It received FDA 510(k) clearance on 2011-07-20 under 510(k) number K102401. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMI IMPLANT; MINI HEMI IMPLANT?

HEMI IMPLANT; MINI HEMI IMPLANT is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Vilex, Inc.. The 510(k) number is K102401.

When did HEMI IMPLANT; MINI HEMI IMPLANT receive FDA 510(k) clearance?

HEMI IMPLANT; MINI HEMI IMPLANT received FDA 510(k) clearance on 2011-07-20, under 510(k) number K102401.

Who is the listed applicant for HEMI IMPLANT; MINI HEMI IMPLANT?

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 HEMI IMPLANT; MINI HEMI IMPLANT?

The FDA product code for HEMI IMPLANT; MINI HEMI IMPLANT is KWD.

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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 NAILK070052MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATIONK052196VILEX X-FIXK041289TALUS OF VILEX (TOV)K041287VILEX BONE PLATE SYSTEM

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Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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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