SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)— 510(k) K052631

Substantially Equivalent

Depuy Mitek, A Johnson & Johnson Company

FDA 510(k) clearance K052631 for SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE), Substantially Equivalent on 2005-10-21. Applicant: Depuy Mitek, A Johnson & Johnson Company.

Clearance details

Applicant: Depuy Mitek, A Johnson & Johnson Company
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2005-09-26
Decision date: 2005-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwood, MA, US

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.