FDA applicant
Ruthless, LLC Dba Ruthless Spine
FDA records 3 decisions for Ruthless, LLC Dba Ruthless Spine (Irwindale, CA) from 2023 to 2025: 2 510(k) clearances and 1 De Novo grant. All are in product code QWL (Intraoperative Surgical Angle Measurement Tool). Its devices cite 2 predicates, 2 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 Ruthless, LLC Dba Ruthless Spine’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Ruthless, LLC Dba Ruthless Spine’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) Report