Carlsmed, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Carlsmed, Inc.” (first 2020, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 112 days. Since 2017 the median was 112 days, against 115 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 133 |
| 2021 | 1 | 126 |
| 2022 | 3 | 138 |
| 2023 | 2 | 76 |
| 2024 | 8 | 110 |
| 2025 | 4 | 104 |
| 2026 | 3 | 92 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Carlsmed, Inc. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 11 | 11 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Orthopedic (19)
- Radiology (3)
Most recent Carlsmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system | MAX | 2026-05-09 | 92 |
| K260570 | corra cervical plating system | KWQ | 2026-04-22 | 62 |
| K252894 | aprevo® cervical interbody system | ODP | 2026-01-06 | 117 |
| K252611 | aprevo® cervical plating system | KWQ | 2025-12-22 | 126 |
| 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 | 2025-07-07 | 111 |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | MAX | 2025-06-30 | 91 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2025-03-17 | 96 |
| K242599 | aprevo® Digital Planning | LLZ | 2024-12-20 | 112 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | OVD | 2024-12-13 | 18 |
| K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | ODP | 2024-11-15 | 107 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carlsmed, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
CARLSMED, INC. (CARL): EDGAR filings, CIK 1794546. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Carlsmed, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Carlsmed, Inc.” (first 2020, latest 2026), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carlsmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carlsmed, Inc. is 112 days. Since 2017: 112 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Carlsmed, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 11); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 22 Carlsmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Carlsmed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.