APEX KIRSCHNER WIRES AND STEINMANN PINS— 510(k) K112254

Substantially Equivalent

Apex Tools & Orthopedics Co.

FDA 510(k) clearance K112254 for APEX KIRSCHNER WIRES AND STEINMANN PINS, Substantially Equivalent on 2011-10-11. Applicant: Apex Tools & Orthopedics Co..

Clearance details

Applicant: Apex Tools & Orthopedics Co.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2011-08-05
Decision date: 2011-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.