SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM— 510(k) K040096

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K040096 for SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM, Substantially Equivalent on 2004-07-01. Applicant: Spinal Concepts, Inc..

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2004-01-20
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.