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FDA 510(k)

CRANIOFACIAL ANCHORS

K-Number: K974136 · 1998-01-30

ApplicantBiomet, Inc.
Decision Date1998-01-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CRANIOFACIAL ANCHORS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1998-01-30 under 510(k) number K974136. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIOFACIAL ANCHORS?

CRANIOFACIAL ANCHORS is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Biomet, Inc.. The 510(k) number is K974136.

When did CRANIOFACIAL ANCHORS receive FDA 510(k) clearance?

CRANIOFACIAL ANCHORS received FDA 510(k) clearance on 1998-01-30, under 510(k) number K974136.

Who is the listed applicant for CRANIOFACIAL ANCHORS?

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 CRANIOFACIAL ANCHORS?

The FDA product code for CRANIOFACIAL ANCHORS is MBI.

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Related Devices (Code: MBI)

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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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