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FDA 510(k)

MAGNA ABUTMENT

K-Number: K984297 · 2000-01-28

ApplicantFactor, Ii, Inc.
Decision Date2000-01-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAGNA ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Factor, Ii, Inc.. It received FDA 510(k) clearance on 2000-01-28 under 510(k) number K984297. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNA ABUTMENT?

MAGNA ABUTMENT is a medical device that received FDA 510(k) clearance on 2000-01-28. The listed applicant is Factor, Ii, Inc.. The 510(k) number is K984297.

When did MAGNA ABUTMENT receive FDA 510(k) clearance?

MAGNA ABUTMENT received FDA 510(k) clearance on 2000-01-28, under 510(k) number K984297.

Who is the listed applicant for MAGNA ABUTMENT?

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

What is the FDA product code for MAGNA ABUTMENT?

The FDA product code for MAGNA ABUTMENT is DZE.

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Other records listing Factor, Ii, 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.

K880329FACTOR II PROSTHETIC SILICONE ELASTOMERK831095ROYALE II

Related Devices (Code: DZE)

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

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

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