Fortilink with TiPlus Technology— 510(k) K213493

Name: FDA 510(k) clearance K213493
Creator: U.S. Food and Drug Administration
Published: 2022-01-27

Substantially Equivalent

Paradigm Spine

FDA 510(k) clearance K213493 for Fortilink with TiPlus Technology, Substantially Equivalent on 2022-01-27. Applicant: Paradigm Spine. Device class: 2.

Clearance details

Applicant: Paradigm Spine
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Paradigm Spine

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K071668 — ORTHOBIOM SPINAL SYSTEM2008-07-02
K080963 — DSS STABILIZATION SYSTEM2008-05-02

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.