AAXTER A3 POSTERIOR SPINAL SYSTEM— 510(k) K101374

Substantially Equivalent

Aaxter Co., Ltd.

FDA 510(k) clearance K101374 for AAXTER A3 POSTERIOR SPINAL SYSTEM, Substantially Equivalent on 2011-03-16. Applicant: Aaxter Co., Ltd..

Clearance details

Applicant: Aaxter Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2010-05-17
Decision date: 2011-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.