TRIGEN Low Profile Bone Screws— 510(k) K161264

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K161264 for TRIGEN Low Profile Bone Screws, Substantially Equivalent on 2016-11-23. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2016-05-05
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, 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.