XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM— 510(k) K061854

Substantially Equivalent

Stryker Spine

FDA 510(k) clearance K061854 for XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM, Substantially Equivalent on 2006-07-27. Applicant: Stryker Spine.

Clearance details

Applicant: Stryker Spine
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2006-06-30
Decision date: 2006-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

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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.