SPINAL CONCEPTS, INC. INFIX SYSTEM— 510(k) K031672

Substantially Equivalent

Spinal Concepts, Inc.

FDA 510(k) clearance K031672 for SPINAL CONCEPTS, INC. INFIX SYSTEM, Substantially Equivalent on 2003-08-07. Applicant: Spinal Concepts, Inc..

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2003-05-30
Decision date: 2003-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.