510(k) Report

FDA applicant

Neuropro Spinaljaxx, Inc.

Modesto, CA1 decision2016–20161 recall

FDA records 1 decision for Neuropro Spinaljaxx, Inc. (Modesto, CA) in 2016: 1 510(k) clearance. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 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 Neuropro Spinaljaxx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2016high 1 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Neuropro Spinaljaxx, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neuropro Spinaljaxx, 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, Lumbar1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc. · 20161 recall

The one decision as Neuropro Spinaljaxx, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K152501Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product…Jan 18, 2018Class II