REFIX INTERNAL FRACTURE FIXATION SCREWS— 510(k) K050388

Substantially Equivalent

Xtremi-T, LLC

FDA 510(k) clearance K050388 for REFIX INTERNAL FRACTURE FIXATION SCREWS, Substantially Equivalent on 2005-09-07. Applicant: Xtremi-T, LLC.

Clearance details

Applicant: Xtremi-T, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2005-02-15
Decision date: 2005-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, NJ, US

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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.