b-ONE® Bipolar Head— 510(k) K253357

Substantially Equivalent

B-One Ortho, Corp.

FDA 510(k) clearance K253357 for b-ONE® Bipolar Head, Substantially Equivalent on 2026-04-13. Applicant: B-One Ortho, Corp..

Clearance details

Applicant: B-One Ortho, Corp.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2025-09-30
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Knolls, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.