FDA applicant

Interventional Spine, Inc.

Irvine, CA8 decisions2008–20162 recalls

FDA records 8 decisions for Interventional Spine, Inc. (Irvine, CA) from 2008 to 2016: 8 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and MRW (System, Facet Screw Spinal Device). Its devices cite 12 predicates, 4 of them its own earlier devices. 2 recalls are 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 Interventional Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008high 2 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2019

2008high 1 (2016) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Interventional Spine, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Interventional Spine, 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

Other applicant names beginning “Interventional”

FDA records each applicant name separately; these may or may not be the same firm.

Interventional Therapeutics Corp. 28 Interventional Medical, Inc. 4 Interventional Innovations Corp. 2 Interventional Concepts, Inc. 1 Interventional Research Technologies 1 Interventional Thermodynamics, Inc. 1

Interventional Spine, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Interventional”