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FDA 510(k)

METAL SCREW ANCHOR

K-Number: K012503 · 2001-10-22

ApplicantBiomet Manufacturing, Inc.
Decision Date2001-10-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL SCREW ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K012503. 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 METAL SCREW ANCHOR?

METAL SCREW ANCHOR is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K012503.

When did METAL SCREW ANCHOR receive FDA 510(k) clearance?

METAL SCREW ANCHOR received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012503.

Who is the listed applicant for METAL SCREW ANCHOR?

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

What is the FDA product code for METAL SCREW ANCHOR?

The FDA product code for METAL SCREW ANCHOR is MBI.

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Other records listing Biomet Manufacturing, Inc. as applicant

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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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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