# K943319: Gertie Marx Epi-Spinal Tray

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Specialties, Inc.
- Decided: Jun 30, 1995 after 354 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 24, 2016 · Class II · Z-2868-2016: Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
- Aug 4, 2016 · Class II · Z-2684-2016: Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.

Source page: https://510kreport.com/device/K943319
Methodology: https://510kreport.com/methodology