K962425

Substantially Equivalent

BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)

Applicant: Radi Medical Systems AB
Product code: GAA
Advisory panel: General, Plastic Surgery
Date received: 1996-06-24
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.