Cut Screw - Percutaneous Compression Screw— 510(k) K230397

Substantially Equivalent

GM Dos Reis Industria e Comercio Ltda.

FDA 510(k) clearance K230397 for Cut Screw - Percutaneous Compression Screw, Substantially Equivalent on 2023-06-12. Applicant: GM Dos Reis Industria e Comercio Ltda..

Clearance details

Applicant: GM Dos Reis Industria e Comercio Ltda.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2023-02-14
Decision date: 2023-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Campinas, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.