CTH STABILO TOTAL HIP REPLACEMENT SYSTEM— 510(k) K903976

Substantially Equivalent

Kinamed, Inc.

FDA 510(k) clearance K903976 for CTH STABILO TOTAL HIP REPLACEMENT SYSTEM, Substantially Equivalent on 1991-01-09. Applicant: Kinamed, Inc..

Clearance details

Applicant
Kinamed, Inc.
Product code
Code LZO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

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.