K120942

Substantially Equivalent

PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC

Applicant: Parcus Medical, LLC
Product code: MBI
Advisory panel: Orthopedic
Date received: 2012-03-29
Decision date: 2012-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Sturgeon Bay, WI, 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.