FDA applicant
Innova Spinal Technologies, LLC
FDA records 2 decisions for Innova Spinal Technologies, LLC (Boca Raton, FL) from 2014 to 2015: 2 510(k) clearances. All are in product code MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Innova Spinal Technologies, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Innova Spinal Technologies, LLC’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 “Innova”
FDA records each applicant name separately; these may or may not be the same firm.