510(k) K011390— BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM

Substantially Equivalent

Disc-O-Tech Medical Technologies, Ltd.

Clearance details

Applicant: Disc-O-Tech Medical Technologies, Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2001-05-07
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Herzelia, IL

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.