510(k) Report

FDA applicant

Carlsmed, Inc.

Carlsbad, CA23 decisions2020–20260 recalls

FDA records 23 decisions for Carlsmed, Inc. (Carlsbad, CA) from 2020 to 2026: 23 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and OVD (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 60 predicates, 36 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Carlsmed”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Carlsmed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2020: 12021: 12022: 32023: 22024: 82025: 42026 (partial year): 4
2020high 8 (2024) · low 1 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Carlsmed, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carlsmed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar11decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 23 510(k)s took a median of 111 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 9 of its 23 were faster than that.

Whose devices does it build on?

Its devices cite 60 predicates; 36 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 39 times; 36 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion…Carlsmed, Inc. · 20226cite it
  • K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc. · 20205cite it
  • K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 20225cite it
  • K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion…Carlsmed, Inc. · 20243cite it
  • K252611aprevo® cervical plating systemCarlsmed, Inc. · 20252cite it
  • K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo®…Carlsmed, Inc. · 20252cite it

What has FDA decided for it lately?

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody…Carlsmed, Inc. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026
  • K252894aprevo® cervical interbody systemCarlsmed, Inc. · 2026
  • K252611aprevo® cervical plating systemCarlsmed, Inc. · 2025
  • K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo®…Carlsmed, Inc. · 2025
  • K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc. · 2025
  • K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device…Carlsmed, Inc. · 2025

All 22 as Carlsmed, Inc. →The one decision as Carlsmed →