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FDA 510(k)

UNiD Spine Analyzer

K-Number: K212005 · 2022-01-12

ApplicantMedicrea International, Inc.
Decision Date2022-01-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNiD Spine Analyzer is a medical device manufactured by Medicrea International, Inc.. It received FDA 510(k) clearance on 2022-01-12 under approval number K212005. 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 UNiD Spine Analyzer?

UNiD Spine Analyzer is a medical device that received FDA 510(k) clearance on 2022-01-12. It is manufactured by Medicrea International, Inc.. The 510(k) number is K212005.

When was UNiD Spine Analyzer approved by the FDA?

UNiD Spine Analyzer received FDA 510(k) clearance on 2022-01-12, under approval number K212005.

What company makes UNiD Spine Analyzer?

UNiD Spine Analyzer is manufactured by Medicrea International, Inc..

What is the FDA product code for UNiD Spine Analyzer?

The FDA product code for UNiD Spine Analyzer is LLZ.

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Official Source

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