UNITY BETA PLLA SYSTEM— 510(k) K090175

Substantially Equivalent

Bonutti Research, Inc.

FDA 510(k) clearance K090175 for UNITY BETA PLLA SYSTEM, Substantially Equivalent on 2009-09-10. Applicant: Bonutti Research, Inc..

Clearance details

Applicant: Bonutti Research, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2009-01-23
Decision date: 2009-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Effingham, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.