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FDA 510(k)

THE AUTOTAC SYSTEM

K-Number: K011675 · 2001-06-22

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2001-06-22
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE AUTOTAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2001-06-22 under 510(k) number K011675. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE AUTOTAC SYSTEM?

THE AUTOTAC SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-22. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K011675.

When did THE AUTOTAC SYSTEM receive FDA 510(k) clearance?

THE AUTOTAC SYSTEM received FDA 510(k) clearance on 2001-06-22, under 510(k) number K011675.

Who is the listed applicant for THE AUTOTAC SYSTEM?

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

What is the FDA product code for THE AUTOTAC SYSTEM?

The FDA product code for THE AUTOTAC SYSTEM is DZL.

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Other records listing BioHorizons Implant Systems, Inc. as applicant

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Related Devices (Code: DZL)

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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