OSSTAPLE, OSSPLATE, OSSFORCE— 510(k) K061385

Substantially Equivalent

Biomedical Enterprises, Inc.

FDA 510(k) clearance K061385 for OSSTAPLE, OSSPLATE, OSSFORCE, Substantially Equivalent on 2007-05-30. Applicant: Biomedical Enterprises, Inc..

Clearance details

Applicant: Biomedical Enterprises, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2006-05-18
Decision date: 2007-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.