ENDOSKELETON TC— 510(k) K100889

Substantially Equivalent

Titan Spine, LLC

FDA 510(k) clearance K100889 for ENDOSKELETON TC, Substantially Equivalent on 2010-07-29. Applicant: Titan Spine, LLC.

Clearance details

Applicant: Titan Spine, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2010-03-31
Decision date: 2010-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.