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Mayfield Infinity XR2 Skull Clamp

by Integra Lifesciences Corporation

510(k) K130389

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130389 Date23 Apr 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HBL
Device Class
Class II
Regulation
21 CFR Part 882.4460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mayfield Infinity XR2 Skull Clamp is a multifunctional cranial stabilization and fixation device designed to provide rigid skeletal fixation during diagnostic examination and surgical procedures. It is intended to be used with the Infinity XR2 Base Unit or other compatible base units to support a patient when positional freedom is required and X-ray imaging modalities will be used.

This device is supplied as part of the Mayfield Infinity XR2 Radiolucent System and is designed for use in neurosurgical procedures. It is a Class II medical device cleared by the FDA under 510(k) K130389, with the product code HBL. The device is intended for single use and should be used according to the manufacturer's instructions.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mayfield Infinity XR2 Skull Clamp used for?

    The Mayfield Infinity XR2 Skull Clamp is a multifunctional cranial stabilization and fixation device designed to provide rigid skeletal fixation during diagnostic examination and surgical procedures, particularly when positional freedom is required and X-ray imaging modalities will be used.

  • Is the Mayfield Infinity XR2 Skull Clamp reusable or single-use?

    The Mayfield Infinity XR2 Skull Clamp is intended for single use only and should be used according to the manufacturer's instructions to ensure proper function and patient safety.

  • What base units are compatible with the Mayfield Infinity XR2 Skull Clamp?

    The Mayfield Infinity XR2 Skull Clamp is designed to be used with the Infinity XR2 Base Unit or other compatible base units to support a patient during procedures requiring X-ray imaging.

  • What is the regulatory status of the Mayfield Infinity XR2 Skull Clamp?

    The Mayfield Infinity XR2 Skull Clamp is a Class II medical device cleared by the FDA under 510(k) K130389, with the product code HBL, and is part of the Mayfield Infinity XR2 Radiolucent System.