BONE NAIL, KUNTSCHER— 510(k) K911982

Substantially Equivalent

International Hospital Supply Co.

FDA 510(k) clearance K911982 for BONE NAIL, KUNTSCHER, Substantially Equivalent on 1991-07-26. Applicant: International Hospital Supply Co..

Clearance details

Applicant
International Hospital Supply Co.
Product code
Code HSD
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarzana, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HSD

product code HSD
Injury
3,425
Malfunction
531
Total
3,956

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.