# K090272: Spetzler Scalp Retractor Clamps (Various Styles and Sizes)

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Mar 18, 2009 after 42 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
Longest line of descent: 1 generation back to K895395 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895395: V. Mueller Rhoton Self-Retaining Brain Retractor, Baxter Healthcare Corp (1989) Summary page 1.
- (no number) Leyla Self-Retaining Brain Retractor System: named in the summary without a submission number

## Indications for use
The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are accessories that are intended to be used to assist in the retraction of the scalp during supratentorial and infratentorial skull operations.

Source page: https://510kreport.com/device/K090272
Methodology: https://510kreport.com/methodology