FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)— 510(k) K063009

Substantially Equivalent

Praesidia S.R.L.

FDA 510(k) clearance K063009 for FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES), Substantially Equivalent on 2006-12-27. Applicant: Praesidia S.R.L..

Clearance details

Applicant: Praesidia S.R.L.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2006-10-02
Decision date: 2006-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.