FDA 510(k)

Cannulated Hemi Implant

K-Number: K190543 · 2019-05-31

Decision Date2019-05-31

Product CodeKWD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cannulated Hemi Implant is a medical device manufactured by Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2019-05-31 under approval 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. It is manufactured by Vilex IN Tennessee, Inc.. The 510(k) number is K190543.

When was Cannulated Hemi Implant approved by the FDA?

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

What company makes Cannulated Hemi Implant?

Cannulated Hemi Implant is manufactured by Vilex IN Tennessee, Inc..

What is the FDA product code for Cannulated Hemi Implant?

The FDA product code for Cannulated Hemi Implant is KWD.

Other Devices by Vilex IN Tennessee, Inc.

K151881X-Fix Line Additions K163487Ultima HA Coated Half Pins and Wire K191289Bone Screw Line Addition

Related Devices (Code: KWD)

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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.