510(k) K130434— OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC

Substantially Equivalent

Exactech, Inc.

Clearance details

Applicant: Exactech, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2013-02-21
Decision date: 2013-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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.