AnatomicAligner
K-Number: K190767 · 2020-03-16
Decision Date2020-03-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AnatomicAligner is a medical device manufactured by The Methodist Hospital Research Institute D/B/A Houston. It received FDA 510(k) clearance on 2020-03-16 under approval 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. It is manufactured by The Methodist Hospital Research Institute D/B/A Houston. The 510(k) number is K190767.
When was AnatomicAligner approved by the FDA?
AnatomicAligner received FDA 510(k) clearance on 2020-03-16, under approval number K190767.
What company makes AnatomicAligner?
AnatomicAligner is manufactured by The Methodist Hospital Research Institute D/B/A Houston.
What is the FDA product code for AnatomicAligner?
The FDA product code for AnatomicAligner is LLZ.
Related Devices (Code: LLZ)
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.