MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM— 510(k) K983258

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K983258 for MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM, Substantially Equivalent on 1998-10-21. Applicant: Spinal Concepts, Inc..

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 1998-09-16
Decision date: 1998-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.