510(k) Report

FDA applicant

Zyga Technology, Inc.

Minneapolis, MN6 decisions2010–20150 recalls

FDA records 6 decisions for Zyga Technology, Inc. (Minneapolis, MN) from 2010 to 2015: 6 510(k) clearances. All are in product code OUR (Sacroiliac Joint Fixation). Its devices cite 11 predicates, 5 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 Zyga Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2010: 12011: 22013: 12015: 2
2010high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Zyga Technology, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zyga Technology, Inc.’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