Endoskeleton TCS Interbody Fusion Device— 510(k) K191565

Substantially Equivalent

Titan Spine, Inc.

FDA 510(k) clearance K191565 for Endoskeleton TCS Interbody Fusion Device, Substantially Equivalent on 2019-08-06. Applicant: Titan Spine, Inc..

Clearance details

Applicant: Titan Spine, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2019-06-13
Decision date: 2019-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Mequon, WI, US

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Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.