Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL— 510(k) K142589

Substantially Equivalent

Titan Spine, LLC

FDA 510(k) clearance K142589 for Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL, Substantially Equivalent on 2014-10-17. Applicant: Titan Spine, LLC.

Clearance details

Applicant: Titan Spine, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2014-09-15
Decision date: 2014-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Mequon, WI, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.