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FDA 510(k)

aprevo® Digital Workflow

K-Number: K222195 · 2022-12-30

ApplicantCarlsmed, Inc.
Decision Date2022-12-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

aprevo® Digital Workflow is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2022-12-30 under approval number K222195. 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 aprevo® Digital Workflow?

aprevo® Digital Workflow is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Carlsmed, Inc.. The 510(k) number is K222195.

When was aprevo® Digital Workflow approved by the FDA?

aprevo® Digital Workflow received FDA 510(k) clearance on 2022-12-30, under approval number K222195.

What company makes aprevo® Digital Workflow?

aprevo® Digital Workflow is manufactured by Carlsmed, Inc..

What is the FDA product code for aprevo® Digital Workflow?

The FDA product code for aprevo® Digital Workflow is LLZ.

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Related Devices (Code: 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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