# K960807: Tew Cranial/Spinal Retractor Model A1090

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: May 17, 1996 after 79 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Karlin Crank Frame Spinal Retractor Set: named in the summary without a submission number
- (no number) Apfelbaum Cerebellar Retractor: named in the summary without a submission number
- (no number) Budde® Halo Retractor - for blades, micro-retractors and flex arms: named in the summary without a submission number

## Most influential descendants
- K060097: Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 (2006), 3 descendants of its own
- K180610: Geister retractor for neuro - and spine surgery (2018), 1 descendant of its own
- K252995: Durashield Device Kit (2026), 0 descendants of its own
- K093054: Scalp Dura Retractor, Model KS00474 (2010), 0 descendants of its own

## Indications for use
The TEW Cranial’Spinal Retractor (A-1090) is designed for posterior fossa or intraspinal microsurgery where retraction is required.

Source page: https://510kreport.com/device/K960807
Methodology: https://510kreport.com/methodology