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FDA 510(k)

Precision Align

K-Number: K212772 · 2022-01-15

ApplicantPrecision Align, LLC
Decision Date2022-01-15
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Precision Align is a medical device manufactured by Precision Align, LLC. It received FDA 510(k) clearance on 2022-01-15 under approval number K212772. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Align?

Precision Align is a medical device that received FDA 510(k) clearance on 2022-01-15. It is manufactured by Precision Align, LLC. The 510(k) number is K212772.

When was Precision Align approved by the FDA?

Precision Align received FDA 510(k) clearance on 2022-01-15, under approval number K212772.

What company makes Precision Align?

Precision Align is manufactured by Precision Align, LLC.

What is the FDA product code for Precision Align?

The FDA product code for Precision Align is NXC.

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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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