# K992898: The Bright Medical Dilation Retractor System

- Pathway: 510(k) (Traditional)
- Applicant: Bright Medical Instruments
- Decided: Oct 21, 1999 after 55 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.
25 later devices descend from it; 6 cite it directly.
0 of 26 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) Sofamor Danek MicroEndoscopic Discectomy Retractor System: named in the summary without a submission number

## Most influential descendants
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own
- K180876: DTRAX Spinal System (2018), 7 descendants of its own
- K190201: CORUS Spinal System (2019), 6 descendants of its own
- K212636: CORUS Spinal System-X (2021), 5 descendants of its own

## Indications for use
Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.

Source page: https://510kreport.com/device/K992898
Methodology: https://510kreport.com/methodology