Mayfield®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: MAYFIELD® FDA UDI
Generic Name: Skull clamp FDA UDI
Device Name: MAYFIELD® Reusable Titanium Skull Pin, Child FDA UDI
Model / Reference: A1122 FDA UDI
Description: MAYFIELD® Reusable Titanium Skull Pin, Child FDA UDI

Identifiers

Catalog Number: A1122 FDA UDI
Primary DI / UDI-DI: 10381780253648 FDA UDI
510(k) Number: K072208 FDA UDI
FDA Product Code: HBL FDA UDI
GMDN Term: Skull clamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4460 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Skull clamp

Mayfield® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skull clamp.

DORO® Base Unit — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
DORO® Skull Clamp System — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
ClearPoint — Clearpoint Neuro, Inc. · Class II
DORO® pin holder — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
DORO® Quick-Clamp — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
V. Mueller — STERIS CORPORATION · Class II
ClearPoint — Clearpoint Neuro, Inc. · Class II
DORO® Base Unit Radiolucent — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II

Cleared under the same submission

K072208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 9c73b450-e747-4d78-912d-be62deac3cfd 37 fields · synced Jun 8, 2026