CONFIDENCE HIGH VISCOSITY BONE CEMENT— 510(k) K060300

Substantially Equivalent

Disc-O-Tech Medical Technologies, Ltd.

FDA 510(k) clearance K060300 for CONFIDENCE HIGH VISCOSITY BONE CEMENT, Substantially Equivalent on 2006-06-21. Applicant: Disc-O-Tech Medical Technologies, Ltd..

Clearance details

Applicant: Disc-O-Tech Medical Technologies, Ltd.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2006-02-06
Decision date: 2006-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzliya, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.