Carlsmed, Inc. FDA Approvals

0 new drug approvals and 21 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
corra® cervical plating system510(k)Sep 24, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 24, 2026
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system510(k)May 9, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 9, 2026
corra cervical plating system510(k)Apr 22, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 22, 2026
aprevo® cervical interbody system510(k)Jan 6, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 6, 2026
aprevo® cervical plating system510(k)Dec 22, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 22, 2025
aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams510(k)Jul 7, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 7, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device510(k)Jun 30, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 30, 2025
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation510(k)Mar 17, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 17, 2025
aprevo® Digital Planning510(k)Dec 20, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 20, 2024
aprevo® anterior lumbar interbody fusion device with interfixation510(k)Dec 13, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 13, 2024
aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM510(k)Nov 15, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
aprevo® anterior lumbar interbody fusion device with interfixation510(k)Oct 9, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 9, 2024
aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device510(k)Sep 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 20, 2024
aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X)510(k)Aug 12, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 12, 2024
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device510(k)Mar 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 22, 2024
aprevo® Digital Segmentation510(k)Nov 3, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 3, 2023
aprevo® transforaminal lumbar interbody fusion device510(k)May 19, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 19, 2023
aprevo® Digital Workflow510(k)Dec 30, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 30, 2022
aprevo® anterior lumbar interbody fusion device with interfixation510(k)Nov 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 22, 2022
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices510(k)Aug 12, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 12, 2022
aprevo Transforaminal IBF510(k)Jun 30, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 30, 2021

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