510(k) Report

FDA applicant

Kfx Medical

Carlsbad, CA7 decisions2006–20120 recalls

FDA records 7 decisions for Kfx Medical (Carlsbad, CA) from 2006 to 2012: 7 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 9 predicates, 3 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 Kfx Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 22009: 12010: 12012: 1
2007high 2 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kfx Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kfx Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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