FDA applicant
Nuvasive, Inc.
FDA records 94 decisions for Nuvasive, Inc. (San Diego, CA) from 1999 to 2024: 92 510(k) clearances and 2 original PMA approvals. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 50 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 155 predicates, 61 of them its own earlier devices. 34 recalls are linked to its devices.
FDA’s records also spell it “Nuvasive”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nuvasive, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like Nuvasive, 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) ReportOther applicant names beginning “Nuvasive”
FDA records each applicant name separately; these may or may not be the same firm.