Ideal pedicle screw spinal system— 510(k) K142957

Substantially Equivalent

Jiangsu Ideal Medical Science & Technology Co., Ltd.

FDA 510(k) clearance K142957 for Ideal pedicle screw spinal system, Substantially Equivalent on 2015-01-30. Applicant: Jiangsu Ideal Medical Science & Technology Co., Ltd..

Clearance details

Applicant
Jiangsu Ideal Medical Science & Technology Co., Ltd.
Product code
Code MNH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zhangjiagang, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code MNH

product code MNH
Injury
978
Malfunction
793
Total
1,771

Source: openFDA MAUDE database, through . 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.