Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Zyga Technology, Inc. · Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

43 daysmedian FDA review time
218 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151818SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2015-08-05300
K141549SImmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2015-01-152180
K130092SIMMETRY SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.2013-02-27430
K111801SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.2011-07-21240
K110512SIMMETRY SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.2011-03-23280
K102907SIMMETRY SACROILIAC JOINT FUSION SYSTEMZyga Technology, Inc.2010-12-14740

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda