510(k) K101471— AXLE INTERSPINOUS FUSION SYSTEM

Substantially Equivalent

X-Spine Systems, Inc.

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2010-05-27
Decision date: 2010-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.