Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Carlsmed, Inc. — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

112 daysmedian FDA review time

138 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K260385	aprevo® anterior and lateral lumbar interbody system; aprevo	Carlsmed, Inc.	2026-05-09	92
K260570	corra™ cervical plating system	Carlsmed, Inc.	2026-04-22	62
K252894	aprevo® cervical interbody system	Carlsmed, Inc.	2026-01-06	117
K252611	aprevo® cervical plating system	Carlsmed, Inc.	2025-12-22	126
K250827	aprevo® anterior lumbar interbody fusion device; aprevo® lat	Carlsmed, Inc.	2025-07-07	111
K250987	aprevo® posterior/transforaminal lumbar interbody fusion dev	Carlsmed, Inc.	2025-06-30	91
K243802	aprevo® anterior and lateral lumbar interbody fusion device,	Carlsmed, Inc.	2025-03-17	96
K242599	aprevo® Digital Planning	Carlsmed, Inc.	2024-12-20	112
K243635	aprevo® anterior lumbar interbody fusion device with interfi	Carlsmed, Inc.	2024-12-13	18
K242260	aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cerv	Carlsmed, Inc.	2024-11-15	107
K241477	aprevo® anterior lumbar interbody fusion device with interfi	Carlsmed, Inc.	2024-10-09	138
K241332	aprevo® anterior and lateral lumbar interbody fusion device;	Carlsmed, Inc.	2024-09-20	133
K241328	aprevo® Anterior and Lateral Lumbar Interbody Fusion device	Carlsmed, Inc.	2024-08-12	94
K232282	aprevo® anterior and lateral lumbar interbody fusion device,	Carlsmed, Inc.	2024-03-22	235
K231955	aprevo® Digital Segmentation	Carlsmed, Inc.	2023-11-03	123
K231140	aprevo® transforaminal lumbar interbody fusion device	Carlsmed, Inc.	2023-05-19	28
K222195	aprevo® Digital Workflow	Carlsmed, Inc.	2022-12-30	161
K222009	aprevo® anterior lumbar interbody fusion device with interfi	Carlsmed, Inc.	2022-11-22	138
K222082	aprevo® anterior and lateral lumbar interbody fusion devices	Carlsmed, Inc.	2022-08-12	28
K210542	aprevo Transforaminal IBF	Carlsmed, Inc.	2021-06-30	126
K202034	aprevo Intervertebral Body Fusion Device	Carlsmed, Inc.	2020-12-03	133

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda