Fortilink with TiPlus Technology— 510(k) K213493

Substantially Equivalent

Paradigm Spine

FDA 510(k) clearance K213493 for Fortilink with TiPlus Technology, Substantially Equivalent on 2022-01-27. Applicant: Paradigm Spine.

Clearance details

Applicant: Paradigm Spine
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2021-11-01
Decision date: 2022-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wurmlingen Baden-Wurttemberg, DE

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.