LATERAL SYNFIX— 510(k) K131276

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K131276 for LATERAL SYNFIX, Substantially Equivalent on 2014-01-06. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2013-05-06
Decision date: 2014-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.