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FDA 510(k)

aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM

K-Number: K242260 · 2024-11-15

ApplicantCarlsmed, Inc.
Decision Date2024-11-15
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2024-11-15 under approval number K242260. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM?

aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Carlsmed, Inc.. The 510(k) number is K242260.

When was aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM approved by the FDA?

aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM received FDA 510(k) clearance on 2024-11-15, under approval number K242260.

What company makes aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM?

aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM is manufactured by Carlsmed, Inc..

What is the FDA product code for aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM?

The FDA product code for aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM is ODP.

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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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