Medical Device Manufacturer · US , La Jolla , CA

Carlsmed, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2020
20
Total
20
Cleared
0
Denied

Carlsmed, Inc. has 20 FDA 510(k) cleared orthopedic devices. Based in La Jolla, US.

Latest FDA clearance: Apr 2026. Active since 2020.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Karen Liu Consulting as regulatory consultant.

FDA 510(k) Regulatory Record - Carlsmed, Inc.
20 devices
1-20 of 20
Cleared Apr 22, 2026
corra™ cervical plating system
K260570 · KWQ
Orthopedic · 62d
Cleared Jan 06, 2026
aprevo® cervical interbody system
K252894 · ODP
Orthopedic · 117d
Cleared Dec 22, 2025
aprevo® cervical plating system
K252611 · KWQ
Orthopedic · 126d
Cleared Jul 07, 2025
aprevo® anterior lumbar interbody fusion device
K250827 · MAX
Orthopedic · 111d
Cleared Jun 30, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
K250987 · MAX
Orthopedic · 91d
Cleared Mar 17, 2025
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior...
K243802 · OVD
Orthopedic · 96d
Cleared Dec 20, 2024
aprevo® Digital Planning
K242599 · LLZ
Radiology · 112d
Cleared Dec 13, 2024
aprevo® anterior lumbar interbody fusion device with interfixation
K243635 · OVD
Orthopedic · 18d
Cleared Nov 15, 2024
aprevo® Cervical ACDF
K242260 · ODP
Orthopedic · 107d
Cleared Oct 09, 2024
aprevo® anterior lumbar interbody fusion device with interfixation
K241477 · OVD
Orthopedic · 138d
Cleared Sep 20, 2024
aprevo® anterior and lateral lumbar interbody fusion device
K241332 · MAX
Orthopedic · 133d
Cleared Aug 12, 2024
aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF)
K241328 · MAX
Orthopedic · 94d
Cleared Mar 22, 2024
aprevo® anterior and lateral lumbar interbody fusion device, aprevo®...
K232282 · MAX
Orthopedic · 235d
Cleared Nov 03, 2023
aprevo® Digital Segmentation
K231955 · QIH
Radiology · 123d
Cleared May 19, 2023
aprevo® transforaminal lumbar interbody fusion device
K231140 · MAX
Orthopedic · 28d
Cleared Dec 30, 2022
aprevo® Digital Workflow
K222195 · LLZ
Radiology · 161d
Cleared Nov 22, 2022
aprevo® anterior lumbar interbody fusion device with interfixation
K222009 · OVD
Orthopedic · 138d
Cleared Aug 12, 2022
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo®...
K222082 · MAX
Orthopedic · 28d
Cleared Jun 30, 2021
aprevo Transforaminal IBF
K210542 · MAX
Orthopedic · 126d
Cleared Dec 03, 2020
aprevo Intervertebral Body Fusion Device
K202034 · MAX
Orthopedic · 133d
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