510(k) Report

FDA applicant

Nlt Spine, Ltd.

Washington, DC8 decisions2011–20160 recalls

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, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Nlt Spine, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2011: 12012: 12013: 32015: 12016: 2
2011high 3 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Nlt Spine, Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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