510(k) K111883— SMARTLOC SPINAL FIXATION SYSTEM

Substantially Equivalent

A-Spine Asia, Co., Ltd.

Clearance details

Applicant: A-Spine Asia, Co., Ltd.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2011-07-01
Decision date: 2011-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, Neihu District, TW

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.