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FDA 510(k)

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system

K-Number: K260385 · 2026-05-09

ApplicantCarlsmed, Inc.
Decision Date2026-05-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system is a medical device manufactured by Carlsmed, Inc.. It received FDA 510(k) clearance on 2026-05-09 under approval number K260385. 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® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system?

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system is a medical device that received FDA 510(k) clearance on 2026-05-09. It is manufactured by Carlsmed, Inc.. The 510(k) number is K260385.

When was aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system approved by the FDA?

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system received FDA 510(k) clearance on 2026-05-09, under approval number K260385.

What company makes aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system?

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system is manufactured by Carlsmed, Inc..

What is the FDA product code for aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system?

The FDA product code for aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system is MAX.

Related Devices (Code: MAX)

K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc. K260837VersaLift Expandable SystemLife Spine, Inc. K261067BEE PLIF CageNGMedical GmbH

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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