PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258— 510(k) K090075

Substantially Equivalent

Parcus Medical, LLC

FDA 510(k) clearance K090075 for PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258, Substantially Equivalent on 2009-03-06. Applicant: Parcus Medical, LLC.

Clearance details

Applicant: Parcus Medical, LLC
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2009-01-12
Decision date: 2009-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
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.