MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K062831

Substantially Equivalent

Life Spine

FDA 510(k) clearance K062831 for MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2006-10-19. Applicant: Life Spine.

Clearance details

Applicant: Life Spine
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2006-09-20
Decision date: 2006-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hoffman Estates, IL, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.