Chrysalis Intelligence · Sponsors · Carlsmed, Inc.

Carlsmed, Inc.

Carlsbad, CA, US · 22 510(k) clearances

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Total clearances
22
2020-12-03 → 2026-05-09
Last 12 months
4
Product codes
6
Most recent
2026-05-09
Name variants in FDA filings: Carlsmed, Inc. / Carlsmed
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 11 2026-05-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 4 2025-03-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 2 2026-04-22
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 2 2026-01-06
LLZ System, Image Processing, Radiological Class II Radiology 2 2024-12-20
QIH Automated Radiological Image Processing Software Class II Radiology 1 2023-11-03
Filings

All 510(k) clearances (22)

Date K-number Device Code Class Specialty
2026-05-09 K260385 aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system MAX Class II Orthopedic
2026-04-22 K260570 corra™ cervical plating system KWQ Class II Orthopedic
2026-01-06 K252894 aprevo® cervical interbody system ODP Class II Orthopedic
2025-12-22 K252611 aprevo® cervical plating system KWQ Class II Orthopedic
2025-07-07 K250827 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 MAX Class II Orthopedic
2025-06-30 K250987 aprevo® posterior/transforaminal lumbar interbody fusion device MAX Class II Orthopedic
2025-03-17 K243802 aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation OVD Class II Orthopedic
2024-12-20 K242599 aprevo® Digital Planning LLZ Class II Radiology
2024-12-13 K243635 aprevo® anterior lumbar interbody fusion device with interfixation OVD Class II Orthopedic
2024-11-15 K242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM ODP Class II Orthopedic
2024-10-09 K241477 aprevo® anterior lumbar interbody fusion device with interfixation OVD Class II Orthopedic
2024-09-20 K241332 aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device MAX Class II Orthopedic
2024-08-12 K241328 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) MAX Class II Orthopedic
2024-07-09 K241019 aprevo® TLIF-C Articulating System MAX Class II Orthopedic
2024-03-22 K232282 aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device MAX Class II Orthopedic
2023-11-03 K231955 aprevo® Digital Segmentation QIH Class II Radiology
2023-05-19 K231140 aprevo® transforaminal lumbar interbody fusion device MAX Class II Orthopedic
2022-12-30 K222195 aprevo® Digital Workflow LLZ Class II Radiology
2022-11-22 K222009 aprevo® anterior lumbar interbody fusion device with interfixation OVD Class II Orthopedic
2022-08-12 K222082 aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices MAX Class II Orthopedic
2021-06-30 K210542 aprevo Transforaminal IBF MAX Class II Orthopedic
2020-12-03 K202034 aprevo Intervertebral Body Fusion Device MAX Class II Orthopedic
Data source: openFDA · Generated 2026-08-25 09:34 · Last ingest 2026-08-25T13:34:26.283111 · Pipeline: Chrysalis Intelligence