MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS)— 510(k) K901507

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K901507 for MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS), Substantially Equivalent on 1992-01-28. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1990-03-30
Decision date: 1992-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

Download summary PDF View on FDA.gov ↗

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.