STAINLESS STEEL SPINAL SYSTEM— 510(k) K120829

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K120829 for STAINLESS STEEL SPINAL SYSTEM, Substantially Equivalent on 2012-05-30. Applicant: Theken Spine, LLC.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2012-03-19
Decision date: 2012-05-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Medina, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.