GERTIE MARX EPI-SPINAL TRAY— 510(k) K943319

Unknown

Spinal Specialties, Inc.

FDA 510(k) clearance K943319 for GERTIE MARX EPI-SPINAL TRAY, Unknown on 1995-06-30. Applicant: Spinal Specialties, Inc..

Clearance details

Applicant: Spinal Specialties, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1994-07-11
Decision date: 1995-06-30
Decision: Unknown
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.