ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION— 510(k) K001535

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K001535 for ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION, Substantially Equivalent on 2001-03-20. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2000-05-17
Decision date: 2001-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.