# K090695: Dinkler Surgical Skull Clamp, Model 0308

- Pathway: 510(k) (Traditional)
- Applicant: Dinkler Surgical Devices, Inc.
- Decided: Apr 23, 2009 after 38 days
- Product code: HBL (Holder, Head, Neurosurgical (Skull Clamp))
- Device class: 2
- Regulation: 21 CFR 882.4460
- 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 K932807 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932807: Mayfield* a-2000 Skull Clamp, Ohio Medical Instrument Co., Inc. (1993) Summary page 2.
- K955012: Mizuho Radiolucent Head Frame, Mizuho America, Inc. (1996)

## Indications for use
The Dinkler Surgical Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.

Source page: https://510kreport.com/device/K090695
Methodology: https://510kreport.com/methodology