# K032970: Acra-Cut Xpress 120

- Pathway: 510(k) (Traditional)
- Applicant: Acra Cut, Inc.
- Decided: Dec 8, 2003 after 76 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Osteomed B Power System: named in the summary without a submission number
- (no number) Stryker System II Orthopower 90 Battery Powered Instruments: named in the summary without a submission number
- (no number) ACRA-CUT perforators: named in the summary without a submission number

## Indications for use
This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not take the place of the surgeon, it is only a tool to assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.

Source page: https://510kreport.com/device/K032970
Methodology: https://510kreport.com/methodology