SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K990005

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K990005 for SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 1999-02-12. Applicant: Spinal Concepts, Inc..

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1999-01-04
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.