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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 the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International, Inc.. It received FDA 510(k) clearance on 2022-01-12 under 510(k) 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. The listed applicant is Medicrea International, Inc.. The 510(k) number is K212005.

When did UNiD Spine Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for UNiD Spine Analyzer?

The FDA 510(k) record lists Medicrea International, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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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