GERTIE MARX EPI-SPINAL TRAY— 510(k) K943319
UnknownSpinal Specialties, Inc.
FDA 510(k) clearance K943319 for GERTIE MARX EPI-SPINAL TRAY, Unknown on 1995-06-30. Applicant: Spinal Specialties, Inc.. Device class: 2.
Clearance details
- Applicant
- Spinal Specialties, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code CAZ
view allMore clearances from Spinal Specialties, Inc.
view allAdverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K943319
K-number listed on FDA's recall record- Z-2868-2016 — PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
- Z-2684-2016 — INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943319.
Data sourced from openFDA. This site is unofficial and independent of the FDA.