K873507

Substantially Equivalent

LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM

Applicant
Link America, Inc.
Product code
JDR
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
East Hanavor, NJ, 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.