VHS PEDIATRIC HIP SCREW SYSTEM— 510(k) K011603

Substantially Equivalent

Walter Abendschein, M.D.

FDA 510(k) clearance K011603 for VHS PEDIATRIC HIP SCREW SYSTEM, Substantially Equivalent on 2001-08-15. Applicant: Walter Abendschein, M.D..

Clearance details

Applicant
Walter Abendschein, M.D.
Product code
Code KTT
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chevy Chase, MD, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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.