FDA applicant
Neurostructures, Inc.
FDA records 19 decisions for Neurostructures, Inc. (Irvine, CA) from 2012 to 2020: 19 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 71 predicates, 18 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Neurostructures, LLC”, “Neurostructures”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neurostructures, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Neurostructures, 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