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FDA 510(k)

aprevo® TLIF-C Articulating System

K-Number: K241019 · 2024-07-09

ApplicantCarlsmed
Decision Date2024-07-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo® TLIF-C Articulating System is a medical device manufactured by Carlsmed. It received FDA 510(k) clearance on 2024-07-09 under approval number K241019. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the aprevo® TLIF-C Articulating System?

aprevo® TLIF-C Articulating System is a medical device that received FDA 510(k) clearance on 2024-07-09. It is manufactured by Carlsmed. The 510(k) number is K241019.

When was aprevo® TLIF-C Articulating System approved by the FDA?

aprevo® TLIF-C Articulating System received FDA 510(k) clearance on 2024-07-09, under approval number K241019.

What company makes aprevo® TLIF-C Articulating System?

aprevo® TLIF-C Articulating System is manufactured by Carlsmed.

What is the FDA product code for aprevo® TLIF-C Articulating System?

The FDA product code for aprevo® TLIF-C Articulating System is MAX.

Related Devices (Code: MAX)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.