Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device— 510(k) K173535

Substantially Equivalent

Titan Spine, LLC

FDA 510(k) clearance K173535 for Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device, Substantially Equivalent on 2018-02-13. Applicant: Titan Spine, LLC.

Clearance details

Applicant: Titan Spine, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2017-11-15
Decision date: 2018-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mequon, WI, US

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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.