PLATEAU SPACER SYSTEM— 510(k) K121116

Substantially Equivalent

Life Spine

FDA 510(k) clearance K121116 for PLATEAU SPACER SYSTEM, Substantially Equivalent on 2012-05-08. Applicant: Life Spine.

Clearance details

Applicant: Life Spine
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2012-04-12
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoffman Est, IL, US

Download summary PDF View on FDA.gov ↗

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.