QWIX POSITIONING SCREW— 510(k) K071639

Substantially Equivalent

Newdeal Sas

FDA 510(k) clearance K071639 for QWIX POSITIONING SCREW, Substantially Equivalent on 2007-07-09. Applicant: Newdeal Sas.

Clearance details

Applicant: Newdeal Sas
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2007-06-15
Decision date: 2007-07-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Planisboro, NJ, US

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.