STAXX FX SYSTEM— 510(k) K053336

Substantially Equivalent

Spine Wave, Inc.

FDA 510(k) clearance K053336 for STAXX FX SYSTEM, Substantially Equivalent on 2006-07-03. Applicant: Spine Wave, Inc..

Clearance details

Applicant: Spine Wave, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2005-12-01
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.