GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +— 510(k) K103070

Substantially Equivalent

G Surgical Co., Ltd.

FDA 510(k) clearance K103070 for GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +, Substantially Equivalent on 2011-01-12. Applicant: G Surgical Co., Ltd..

Clearance details

Applicant: G Surgical Co., Ltd.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2010-10-18
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangkok, TH

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.