Gemmed pedicle screw spinal system— 510(k) K151592

Substantially Equivalent

Suzhou Gemmed Medical Instrument Co., Ltd.

FDA 510(k) clearance K151592 for Gemmed pedicle screw spinal system, Substantially Equivalent on 2015-09-24. Applicant: Suzhou Gemmed Medical Instrument Co., Ltd..

Clearance details

Applicant: Suzhou Gemmed Medical Instrument Co., Ltd.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2015-06-12
Decision date: 2015-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangjiagang City, CN

Download summary PDF View on FDA.gov ↗

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.