FDA applicant
Seaspine, Inc.
FDA records 33 decisions for Seaspine, Inc. (Vista, CA) from 2003 to 2023: 33 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 117 predicates, 36 of them its own earlier devices. 14 recalls are linked to its devices.
FDA’s records also spell it “Seaspine”, “Seaspine Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Seaspine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
4in 2014
Class I Class II/III not classified
Planning a device like Seaspine, 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 “Seaspine”
FDA records each applicant name separately; these may or may not be the same firm.