Endoskeleton TAS Plate— 510(k) K192054

Substantially Equivalent

Titan Spine, Inc.

FDA 510(k) clearance K192054 for Endoskeleton TAS Plate, Substantially Equivalent on 2019-08-29. Applicant: Titan Spine, Inc..

Clearance details

Applicant: Titan Spine, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2019-07-31
Decision date: 2019-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Mequon, WI, US

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.