FDA applicant
Zyga Technology, Inc.
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
How often FDA has decided Zyga Technology, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2015
2010high 2 (2011) · low 0 (2012)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
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