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FDA 510(k)

BIOMET CRANIOFACIAL ACRYLIC CEMENT

K-Number: K011399 · 2003-05-05

ApplicantBiomet, Inc.
Decision Date2003-05-05
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOMET CRANIOFACIAL ACRYLIC CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2003-05-05 under 510(k) number K011399. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET CRANIOFACIAL ACRYLIC CEMENT?

BIOMET CRANIOFACIAL ACRYLIC CEMENT is a medical device that received FDA 510(k) clearance on 2003-05-05. The listed applicant is Biomet, Inc.. The 510(k) number is K011399.

When did BIOMET CRANIOFACIAL ACRYLIC CEMENT receive FDA 510(k) clearance?

BIOMET CRANIOFACIAL ACRYLIC CEMENT received FDA 510(k) clearance on 2003-05-05, under 510(k) number K011399.

Who is the listed applicant for BIOMET CRANIOFACIAL ACRYLIC CEMENT?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMET CRANIOFACIAL ACRYLIC CEMENT?

The FDA product code for BIOMET CRANIOFACIAL ACRYLIC CEMENT is GXP.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: GXP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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