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General product and regulatory information only. This page is not medical advice and does not describe how to use or place the device.
Short answer
A Mayfield head holder is a neurosurgical skull clamp: a device that clamps the patient’s skull to hold the head and neck in a set position during surgery. “Mayfield” is a name that appears on many FDA 510(k) clearances; the regulatory category is the neurosurgical head holder (skull clamp), 21 CFR 882.4460, Class II, product code HBL.
Definition and scope
Under 21 CFR 882.4460(a), a neurosurgical head holder (skull clamp) is “a device used to clamp the patient’s skull to hold head and neck in a particular position during surgical procedures.” Paragraph (b) classifies it as Class II (performance standards) (eCFR, checked 2026-10-30).
FDA’s product classification data lists the device as “Holder, Head, Neurosurgical (Skull Clamp)”, product code HBL, review panel Neurology, device class 2, regulation number 882.4460, submitted through the 510(k) route, and not an implant (openFDA classification record, checked 2026-10-30).
The search terms Mayfield skull clamp, Mayfield head clamp and head holder all point to this one regulatory type. The same category also covers products sold under other names, as the table below shows.
How it is used in practice
The regulation’s own wording is the use statement: the clamp holds the head and neck in a particular position during surgical procedures. One Mayfield clamp clearance (K142238, decided 2014-11-24, submitted by Integra LifeSciences Corporation) appears in openFDA under the device name “MAYFIELD Skull Clamp”. This page does not cover pin placement, positioning or any other procedural step; those belong to the manufacturer’s instructions for use and to trained surgical teams.
Mayfield-named clearances in FDA’s database
openFDA’s 510(k) database holds 50 clearances under product code HBL, with decision dates from 1982 to 2025. Seventeen carry “Mayfield” in the device name. A selection, as listed by FDA (checked 2026-10-30):
| K number | Decision date | Submitter | Device name as listed |
|---|---|---|---|
| K932807 | 1993-09-28 | Ohio Medical Instrument Co., Inc. | MAYFIELD* A-2000 SKULL CLAMP |
| K934289 | 1994-01-07 | Ohio Medical Instrument Co., Inc. | MAYFIELD RADIOLUCENT SKULL CLAMP |
| K050319 | 2005-03-31 | Integra Lifesciences Corp. | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 |
| K051440 | 2005-09-20 | Integra Lifesciences Corp. | MAYFIELD INFINITY SKULL CLAMP |
| K072208 | 2007-09-07 | Integra LifeSciences Corporation | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS |
| K090506 | 2009-04-20 | Integra LifeSciences Corporation | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 |
| K142238 | 2014-11-24 | Integra LifeSciences Corporation | MAYFIELD Skull Clamp |
Two patterns are visible in the record. First, the submitter on Mayfield-named entries is Ohio Medical Instrument Co., Inc. in the 1990s and early 2000s and Integra from 2005 onward. Second, skull pins are cleared as their own entries under the same product code, separate from the clamps.
Related terms and neighbouring devices
Head clamp, skull clamp and head holder
These are the same regulatory type, 882.4460. Other firms’ clearances under HBL use names such as CODMAN SKULL CLAMP (K912011), PSI SKULL CLAMP (K002276), DINKLER SURGICAL SKULL CLAMP (K090695) and DORO LUCENT Skull Clamp (K240319), all as listed by FDA.
Skull tongs
Skull tongs are a different device from a skull clamp; see Gardner-Wells tongs for how that device is named and classified.
Head positioners
A head positioner is a separate device family from a rigid skull-fixation clamp. For the wider instrument set, see neurosurgical instruments by type and FDA class.
Where it matters for labs, clinics and supply decisions
What FDA’s records show, and what follows from them for a catalogue or specification review:
- The category is Class II and cleared through 510(k). The clearance logic is explained in the FDA 510(k) premarket notification guide.
- Clearances are per model. Clamps, pins and clamp variants each appear as separate K numbers, so a product name alone does not say which clearance covers it. The K number and model name belong in the product’s labeling.
- Names in the record signal imaging variants. Entries are titled “Radiolucent”, “MR/CT” and “MR/X-ray”. What each model supports is stated in that model’s labeling, not in its category.
- Reuse and reprocessing are product-specific. The record lists reusable and disposable pins as distinct entries. Reprocessing rules are covered in medical device reprocessing; follow the manufacturer’s instructions for use for each model.
Common misunderstandings
- “Mayfield” is not the name of the device class. It is a name on clearances; the class is the neurosurgical head holder (skull clamp).
- The clamp is not the same as skull tongs. Skull tongs are a different device with their own entry; see the Gardner-Wells tongs guide.
- Clearance is not approval. A 510(k) clearance is a different pathway from PMA approval; see FDA clearance vs. approval.
- The category does not tell you MR or CT compatibility. That is a model-level labeling statement.
FAQ
What is a Mayfield head holder?
A neurosurgical skull clamp used to hold the head and neck in a particular position during surgery. Mayfield is a name on FDA 510(k) clearances in this category.
Is a Mayfield skull clamp the same as a head clamp?
Yes in regulatory terms. Head holder, head clamp and skull clamp all refer to 21 CFR 882.4460.
What FDA class is a skull clamp?
Class II, product code HBL, regulation 882.4460, cleared through 510(k).
Are the skull pins part of the clamp?
FDA’s database lists skull pins as their own 510(k) entries under the same product code, separate from clamps.
Sources
- 21 CFR 882.4460, Neurosurgical head holder (skull clamp), eCFR via law.cornell.edu/cfr/text/21/882.4460, checked 2026-10-30.
- openFDA device classification, product code HBL, api.fda.gov/device/classification.json, checked 2026-10-30.
- openFDA 510(k) database, product code HBL (50 records), api.fda.gov/device/510k.json, checked 2026-10-30.
- FDA Product Classification database, HBL, accessdata.fda.gov, checked 2026-10-30.
