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FDA 510(k)

aprevo® Digital Planning

K-Number: K242599 · 2024-12-20

ApplicantCarlsmed, Inc.
Decision Date2024-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

aprevo® Digital Planning is the device name listed in this FDA 510(k) record. The listed applicant is Carlsmed, Inc.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242599. 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 Planning?

aprevo® Digital Planning is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Carlsmed, Inc.. The 510(k) number is K242599.

When did aprevo® Digital Planning receive FDA 510(k) clearance?

aprevo® Digital Planning received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242599.

Who is the listed applicant for aprevo® Digital Planning?

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

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

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

Other records listing Carlsmed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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