510(k) Report

FDA applicant

Curiteva, Inc.

Tanner, AL15 decisions2018–20260 recalls

FDA records 15 decisions for Curiteva, Inc. (Tanner, AL) from 2018 to 2026: 15 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Curiteva, LLC”.

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 Curiteva, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 42019: 12021: 12023: 32024: 32025: 12026 (partial year): 2
2018high 4 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Curiteva, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Curiteva, 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?

  • ODPIntervertebral Fusion Device With Bone Graft, Cervical4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • NQWOrthosis, Spine, Plate, Laminoplasty, Metal2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • OLOOrthopedic Stereotaxic Instrument1decision
  • OURSacroiliac Joint Fixation1decision

Also: OVD (1), NKB (1).

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 85 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; 8 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 41 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 9 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.

  • K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 20233cite it
  • K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC · 20183cite it
  • K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc. · 20242cite it
  • K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC · 20181cites it
  • K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 20241cites it
  • K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc. · 20211cites it

What has FDA decided for it lately?

  • K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva…Curiteva, Inc. · 2026
  • K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2026
  • K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc. · 2025
  • K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc. · 2024
  • K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc. · 2024
  • K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc. · 2024
  • K231232Curiteva Laminoplasty SystemCuriteva, Inc. · 2023
  • K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc. · 2023

All 11 as Curiteva, Inc. →All 4 as Curiteva, LLC →