FDA applicant
Nlt Spine, Ltd.
FDA records 8 decisions for Nlt Spine, Ltd. (Washington, DC) from 2011 to 2016: 8 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and HRX (Arthroscope). Its devices cite 23 predicates, 9 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 Nlt Spine, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Nlt Spine, Ltd.’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