BONE ANCHOR SYSTEM III (BAS III)— 510(k) K990295

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K990295 for BONE ANCHOR SYSTEM III (BAS III), Substantially Equivalent on 1999-03-05. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1999-01-29
Decision date: 1999-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

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.