ADVANCE TIBIAL COMPONENT— 510(k) K960617

Substantially Equivalent for Some Indications

Wrightmedicaltechnologyinc

FDA 510(k) clearance K960617 for ADVANCE TIBIAL COMPONENT, Substantially Equivalent for Some Indications on 1996-05-08. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant
Wrightmedicaltechnologyinc
Product code
Code HRY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Arlington, TN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HRY

product code HRY
Injury
1,551
Malfunction
2,753
Total
4,304

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.