FDA applicant
Spinal Elements, Inc.
FDA records 50 decisions for Spinal Elements, Inc. (Carlsbad, CA) from 2007 to 2026: 50 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 157 predicates, 89 of them its own earlier devices. 23 recalls are linked to its devices.
FDA’s records also spell it “Spinal Elements”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spinal Elements, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Spinal Elements, 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 “Spinal”
FDA records each applicant name separately; these may or may not be the same firm.