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FDA 510(k)

THE AUTOTAC SYSTEM TITANIUM TACK

K-Number: K022790 · 2002-08-28

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2002-08-28
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE AUTOTAC SYSTEM TITANIUM TACK 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 2002-08-28 under 510(k) number K022790. 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 TITANIUM TACK?

THE AUTOTAC SYSTEM TITANIUM TACK is a medical device that received FDA 510(k) clearance on 2002-08-28. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K022790.

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

THE AUTOTAC SYSTEM TITANIUM TACK received FDA 510(k) clearance on 2002-08-28, under 510(k) number K022790.

Who is the listed applicant for THE AUTOTAC SYSTEM TITANIUM TACK?

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 TITANIUM TACK?

The FDA product code for THE AUTOTAC SYSTEM TITANIUM TACK 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.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH

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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