K832301

Substantially Equivalent

DIRECT BONDED BRACKET REMOVER

Applicant: Northwest Orthopedics
Product code: JCX
Advisory panel: General, Plastic Surgery
Date received: 1983-07-13
Decision date: 1983-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.