INFILL CERVICAL— 510(k) K140066

Substantially Equivalent

Pinnacle Spine Group, LLC

FDA 510(k) clearance K140066 for INFILL CERVICAL, Substantially Equivalent on 2014-05-05. Applicant: Pinnacle Spine Group, LLC.

Clearance details

Applicant: Pinnacle Spine Group, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2014-01-10
Decision date: 2014-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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.