510(k) Report

FDA applicant

Spineex, Inc.

Fremont, CA3 decisions2018–20200 recalls

FDA records 3 decisions for Spineex, Inc. (Fremont, CA) from 2018 to 2020: 3 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 31 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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

FDA decisions per year

1in 2020

2018: 12019: 12020: 1
2018high 1 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Spineex, 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, Lumbar3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 31 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. · 20183cite it
  • K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. · 20192cite it
  • K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. · 20201cites it

What has FDA decided for it lately?

  • K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. · 2020
  • K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. · 2019
  • K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc. · 2018

All 3 as Spineex, Inc. →