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FDA 510(k)

STOMA BONE BLOCK SCREW

K-Number: K080430 · 2008-11-21

ApplicantStorz AM Mark GmbH
Decision Date2008-11-21
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STOMA BONE BLOCK SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Storz AM Mark GmbH. It received FDA 510(k) clearance on 2008-11-21 under 510(k) number K080430. 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 STOMA BONE BLOCK SCREW?

STOMA BONE BLOCK SCREW is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Storz AM Mark GmbH. The 510(k) number is K080430.

When did STOMA BONE BLOCK SCREW receive FDA 510(k) clearance?

STOMA BONE BLOCK SCREW received FDA 510(k) clearance on 2008-11-21, under 510(k) number K080430.

Who is the listed applicant for STOMA BONE BLOCK SCREW?

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

What is the FDA product code for STOMA BONE BLOCK SCREW?

The FDA product code for STOMA BONE BLOCK SCREW is DZL.

Related Clinical Trials

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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Other records listing Storz AM Mark GmbH 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.

K051871STOMA BONE SCREW

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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