FDA applicant
Nuvasive Specialized Orthopedics, Inc.
FDA records 25 decisions for Nuvasive Specialized Orthopedics, Inc. (Alisa Viejo, CA) from 2016 to 2026: 25 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and PGN (Growing Rod System- Magnetic Actuation). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 54 predicates, 31 of them its own earlier devices. 8 recalls are linked to its devices.
FDA’s records also spell it “Nuvasive Specialized Orthopedics, Incorporated”, “NuVasive Specialized Orthopedics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nuvasive Specialized Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Nuvasive Specialized Orthopedics, 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.