Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES— 510(k) K133224

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K133224 for Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES, Substantially Equivalent on 2014-01-03. Applicant: Conmed Corporation.

Clearance details

Applicant: Conmed Corporation
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2013-10-21
Decision date: 2014-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, 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.