SMALL PLATEAU SPACER SYSTEM— 510(k) K093093

Substantially Equivalent

Life Spine

FDA 510(k) clearance K093093 for SMALL PLATEAU SPACER SYSTEM, Substantially Equivalent on 2010-10-13. Applicant: Life Spine.

Clearance details

Applicant: Life Spine
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2009-10-01
Decision date: 2010-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.