Chrysalis Intelligence · Sponsors · Carlsmed, Inc.

Carlsmed, Inc.

Carlsbad, CA, US · 23 510(k) clearances

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Total clearances
23
2020-12-03 → 2026-09-24
Last 12 months
5
Product codes
6
Most recent
2026-09-24
Name variants in FDA filings: Carlsmed / Carlsmed, Inc.
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 3 2026-09-24
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 (23)

Date K-number Device Code Class Specialty
2026-09-24 K262149 corra® cervical plating system KWQ Class II Orthopedic
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 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence