BIOKNOTLESS AND LUPINE PLUS ANCHORS— 510(k) K062170

Substantially Equivalent

Depuy Mitek, A Johnson & Johnson Company

FDA 510(k) clearance K062170 for BIOKNOTLESS AND LUPINE PLUS ANCHORS, Substantially Equivalent on 2006-08-22. 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: 2006-07-31
Decision date: 2006-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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.