SImmetry Sacroiliac Joint Fusion System— 510(k) K151818

Substantially Equivalent

Zyga Technology, Inc.

FDA 510(k) clearance K151818 for SImmetry Sacroiliac Joint Fusion System, Substantially Equivalent on 2015-08-05. Applicant: Zyga Technology, Inc..

Clearance details

Applicant: Zyga Technology, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2015-07-06
Decision date: 2015-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.