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FDA 510(k)

Intra medullary endo-transilluminating device (iMET device)

K-Number: K163037 · 2017-02-17

ApplicantWeMED Bio-Tech, Inc.
Decision Date2017-02-17
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Intra medullary endo-transilluminating device (iMET device) is a medical device manufactured by WeMED Bio-Tech, Inc.. It received FDA 510(k) clearance on 2017-02-17 under approval number K163037. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intra medullary endo-transilluminating device (iMET device)?

Intra medullary endo-transilluminating device (iMET device) is a medical device that received FDA 510(k) clearance on 2017-02-17. It is manufactured by WeMED Bio-Tech, Inc.. The 510(k) number is K163037.

When was Intra medullary endo-transilluminating device (iMET device) approved by the FDA?

Intra medullary endo-transilluminating device (iMET device) received FDA 510(k) clearance on 2017-02-17, under approval number K163037.

What company makes Intra medullary endo-transilluminating device (iMET device)?

Intra medullary endo-transilluminating device (iMET device) is manufactured by WeMED Bio-Tech, Inc..

What is the FDA product code for Intra medullary endo-transilluminating device (iMET device)?

The FDA product code for Intra medullary endo-transilluminating device (iMET device) is HRX.

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Related PubMed Literature

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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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