FDA 510(k)

AnatomicAligner

K-Number: K190767 · 2020-03-16

ApplicantThe Methodist Hospital Research Institute D/B/A Houston

Decision Date2020-03-16

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AnatomicAligner is the device name listed in this FDA 510(k) record. The listed applicant is The Methodist Hospital Research Institute D/B/A Houston. It received FDA 510(k) clearance on 2020-03-16 under 510(k) number K190767. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AnatomicAligner?

AnatomicAligner is a medical device that received FDA 510(k) clearance on 2020-03-16. The listed applicant is The Methodist Hospital Research Institute D/B/A Houston. The 510(k) number is K190767.

When did AnatomicAligner receive FDA 510(k) clearance?

AnatomicAligner received FDA 510(k) clearance on 2020-03-16, under 510(k) number K190767.

Who is the listed applicant for AnatomicAligner?

The FDA 510(k) record lists The Methodist Hospital Research Institute D/B/A Houston as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AnatomicAligner?

The FDA product code for AnatomicAligner is LLZ.

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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.