SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS— 510(k) K132366

Substantially Equivalent

Accel Spine

FDA 510(k) clearance K132366 for SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS, Substantially Equivalent on 2013-09-03. Applicant: Accel Spine.

Clearance details

Applicant: Accel Spine
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2013-07-30
Decision date: 2013-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.