MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)— 510(k) K091694

Substantially Equivalent

Tag Medical Products

FDA 510(k) clearance K091694 for MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM), Substantially Equivalent on 2009-07-07. Applicant: Tag Medical Products.

Clearance details

Applicant: Tag Medical Products
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2009-06-10
Decision date: 2009-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerset, MA, 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.