TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM— 510(k) K090024

Substantially Equivalent

Alexandria Research Technologies, LLC

FDA 510(k) clearance K090024 for TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM, Substantially Equivalent on 2009-05-04. Applicant: Alexandria Research Technologies, LLC.

Clearance details

Applicant
Alexandria Research Technologies, LLC
Product code
Code HSX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HSX

product code HSX
Injury
1,003
Other
1
Total
1,004

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.