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FDA 510(k)

Cannulated Hemi Implant

K-Number: K190543 · 2019-05-31

ApplicantVilex IN Tennessee, Inc.
Decision Date2019-05-31
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Hemi Implant is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190543. 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 Cannulated Hemi Implant?

Cannulated Hemi Implant is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K190543.

When did Cannulated Hemi Implant receive FDA 510(k) clearance?

Cannulated Hemi Implant received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190543.

Who is the listed applicant for Cannulated Hemi Implant?

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

What is the FDA product code for Cannulated Hemi Implant?

The FDA product code for Cannulated Hemi Implant is KWD.

Other records listing Vilex IN Tennessee, 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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