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FDA 510(k)

LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM

K-Number: K974392 · 1998-01-30

ApplicantBiovision GmbH
Decision Date1998-01-30
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biovision GmbH. It received FDA 510(k) clearance on 1998-01-30 under 510(k) number K974392. 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 LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM?

LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Biovision GmbH. The 510(k) number is K974392.

When did LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM receive FDA 510(k) clearance?

LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM received FDA 510(k) clearance on 1998-01-30, under 510(k) number K974392.

Who is the listed applicant for LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM?

The FDA 510(k) record lists Biovision GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM?

The FDA product code for LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM is DZL.

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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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