ATLAS SPINE SPACER— 510(k) K091406

Substantially Equivalent

Atlas Spine, LLC

FDA 510(k) clearance K091406 for ATLAS SPINE SPACER, Substantially Equivalent on 2009-09-04. Applicant: Atlas Spine, LLC.

Clearance details

Applicant: Atlas Spine, LLC
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2009-05-12
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jupiter, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.