K041117

Substantially Equivalent

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732

Applicant
Depuy Mitek
Product code
JDR
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Norwood, 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, through . 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.