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FDA 510(k)

aprevo Transforaminal IBF

K-Number: K210542 · 2021-06-30

ApplicantCarlsmed, Inc.
Decision Date2021-06-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo Transforaminal IBF is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2021-06-30 under approval number K210542. 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 Transforaminal IBF?

aprevo Transforaminal IBF is a medical device that received FDA 510(k) clearance on 2021-06-30. It is manufactured by Carlsmed, Inc.. The 510(k) number is K210542.

When was aprevo Transforaminal IBF approved by the FDA?

aprevo Transforaminal IBF received FDA 510(k) clearance on 2021-06-30, under approval number K210542.

What company makes aprevo Transforaminal IBF?

aprevo Transforaminal IBF is manufactured by Carlsmed, Inc..

What is the FDA product code for aprevo Transforaminal IBF?

The FDA product code for aprevo Transforaminal IBF is MAX.

Other Devices by Carlsmed, Inc.

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Related Devices (Code: MAX)

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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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