Medical Device Manufacturer · US , La Jolla , CA

Carlsmed, Inc.

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

Carlsmed, Inc. — FDA 510(k) Submissions

Carlsmed, Inc. has submitted 19 FDA 510(k) premarket notifications since 2020, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Intervertebral Fusion Device With Integrated Fixation, Lumbar, System, Image Processing, Radiological, Intervertebral Fusion Device With Bone Graft, Cervical, Automated Radiological Image Processing Software . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
aprevo? cervical interbody system
K252894 · ODP Intervertebral Fusion... · Orthopedic
Jan 2026 117d
aprevo? cervical plating system
K252611 · KWQ Appliance, Fixation,... · Orthopedic
Dec 2025 126d
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 Cams
K250827 · MAX Intervertebral Fusion... · Orthopedic
Jul 2025 111d
aprevo? posterior/transforaminal lumbar interbody fusion device
K250987 · MAX Intervertebral Fusion... · Orthopedic
Jun 2025 91d
aprevo? anterior and lateral lumbar interbody fusion device, aprevo? anterior lumbar interbody fusion device with interfixation
K243802 · OVD Intervertebral Fusion... · Orthopedic
Mar 2025 96d
aprevo? Digital Planning
K242599 · LLZ System, Image Processing,... · Radiology
Dec 2024 112d
aprevo? anterior lumbar interbody fusion device with interfixation
K243635 · OVD Intervertebral Fusion... · Orthopedic
Dec 2024 18d
aprevo? Cervical ACDF; aprevo? Cervical ACDF-X; aprevo? Cervical ACDF-X NO CAM
K242260 · ODP Intervertebral Fusion... · Orthopedic
Nov 2024 107d
aprevo? anterior lumbar interbody fusion device with interfixation
K241477 · OVD Intervertebral Fusion... · Orthopedic
Oct 2024 138d
aprevo? anterior and lateral lumbar interbody fusion device; aprevo? anterior lumbar interbody fusion devices with interfixation; aprevo? transforaminal lumbar interbody fusion device
K241332 · MAX Intervertebral Fusion... · Orthopedic
Sep 2024 133d
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)
K241328 · MAX Intervertebral Fusion... · Orthopedic
Aug 2024 94d
aprevo? anterior and lateral lumbar interbody fusion device, aprevo? transforaminal lumbar interbody fusion device
K232282 · MAX Intervertebral Fusion... · Orthopedic
Mar 2024 235d
aprevo? Digital Segmentation
K231955 · QIH Automated Radiological... · Radiology
Nov 2023 123d
aprevo? transforaminal lumbar interbody fusion device
K231140 · MAX Intervertebral Fusion... · Orthopedic
May 2023 28d
aprevo? Digital Workflow
K222195 · LLZ System, Image Processing,... · Radiology
Dec 2022 161d
aprevo? anterior lumbar interbody fusion device with interfixation
K222009 · OVD Intervertebral Fusion... · Orthopedic
Nov 2022 138d
aprevo? anterior and lateral lumbar interbody fusion devices, aprevo? transforaminal lumbar interbody fusion devices
K222082 · MAX Intervertebral Fusion... · Orthopedic
Aug 2022 28d
aprevo Transforaminal IBF
K210542 · MAX Intervertebral Fusion... · Orthopedic
Jun 2021 126d
aprevo Intervertebral Body Fusion Device
K202034 · MAX Intervertebral Fusion... · Orthopedic
Dec 2020 133d
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