MULTITAK SS SUTURE SYSTEM— 510(k) K964324

Substantially Equivalent

Bonutti Research

FDA 510(k) clearance K964324 for MULTITAK SS SUTURE SYSTEM, Substantially Equivalent on 1997-01-10. Applicant: Bonutti Research.

Clearance details

Applicant: Bonutti Research
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1996-10-30
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Effingham, IL, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.