FDA 510(k)

MAYFIELD SKULL CLAMP

K-Number: K120633 · 2012-05-24

ApplicantIntegra LifeSciences Corporation

Decision Date2012-05-24

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MAYFIELD SKULL CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K120633. 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 SKULL CLAMP?

MAYFIELD SKULL CLAMP is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K120633.

When did MAYFIELD SKULL CLAMP receive FDA 510(k) clearance?

MAYFIELD SKULL CLAMP received FDA 510(k) clearance on 2012-05-24, under 510(k) number K120633.

Who is the listed applicant for MAYFIELD SKULL CLAMP?

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

What is the FDA product code for MAYFIELD SKULL CLAMP?

The FDA product code for MAYFIELD 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.