Medical Device Manufacturer · US , La Jolla , CA

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

19 submissions · 19 cleared · Since 2020
19
Total
19
Cleared
0
Denied

FDA 510(k) cleared devices by Carlsmed, Inc. Orthopedic

16 devices
1-16 of 16
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 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 May 19, 2023
aprevo® transforaminal lumbar interbody fusion device
K231140 · MAX
Orthopedic · 28d
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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