Hubble II— 510(k) K163180

Substantially Equivalent

Orbbo Surgical, LLC

FDA 510(k) clearance K163180 for Hubble II, Substantially Equivalent on 2016-12-29. Applicant: Orbbo Surgical, LLC.

Clearance details

Applicant: Orbbo Surgical, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2016-11-14
Decision date: 2016-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.