# K050377: NBD Head Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Business Development, LLC
- Decided: Apr 7, 2005 after 51 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K892425 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972324: Leksell Stereotactic System, Elekta Instrument AB (1998) Summary page 2.
- (no number) Radionics accessories: named in the summary without a submission number
- (no number) Leibinger accessories: named in the summary without a submission number
- (no number) Ohio Medical Instruments accessories: named in the summary without a submission number

## Indications for use
The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame.

Source page: https://510kreport.com/device/K050377
Methodology: https://510kreport.com/methodology