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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 the device name listed in this FDA 510(k) record. The listed applicant is WeMED Bio-Tech, Inc.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) 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. The listed applicant is WeMED Bio-Tech, Inc.. The 510(k) number is K163037.

When did Intra medullary endo-transilluminating device (iMET device) receive FDA 510(k) clearance?

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

Who is the listed applicant for Intra medullary endo-transilluminating device (iMET device)?

The FDA 510(k) record lists WeMED Bio-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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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