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

Name: FDA 510(k) clearance K063009
Creator: U.S. Food and Drug Administration
Published: 2006-12-27

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.. Device class: 2.

Clearance details

Applicant: Praesidia S.R.L.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2006-10-02
Decision date: 2006-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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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.