Blustone Synergy Interbody Fusion System— 510(k) K203520

Substantially Equivalent

Blustone Synergy, LLC

FDA 510(k) clearance K203520 for Blustone Synergy Interbody Fusion System, Substantially Equivalent on 2021-04-07. Applicant: Blustone Synergy, LLC.

Clearance details

Applicant: Blustone Synergy, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2020-12-01
Decision date: 2021-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pueblo, CO, 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.