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FDA 510(k)

MAYFIELD MR/X-RAY SKULL CLAMP

K-Number: K081401 · 2008-10-08

ApplicantIntegra Lifesciences Corp.
Decision Date2008-10-08
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAYFIELD MR/X-RAY SKULL CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K081401. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAYFIELD MR/X-RAY SKULL CLAMP?

MAYFIELD MR/X-RAY SKULL CLAMP is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K081401.

When did MAYFIELD MR/X-RAY SKULL CLAMP receive FDA 510(k) clearance?

MAYFIELD MR/X-RAY SKULL CLAMP received FDA 510(k) clearance on 2008-10-08, under 510(k) number K081401.

Who is the listed applicant for MAYFIELD MR/X-RAY SKULL CLAMP?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAYFIELD MR/X-RAY SKULL CLAMP?

The FDA product code for MAYFIELD MR/X-RAY SKULL CLAMP is HBL.

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Related Devices (Code: HBL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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