DePuy Synthes TFNA Augmentation System— 510(k) K160167

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K160167 for DePuy Synthes TFNA Augmentation System, Substantially Equivalent on 2016-09-26. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2016-01-27
Decision date: 2016-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.