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FDA 510(k)

The Micro Screw System, Micro Screw System Basic

K-Number: K201210 · 2021-10-08

ApplicantHager& Meisinger GmbH
Decision Date2021-10-08
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

The Micro Screw System, Micro Screw System Basic is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K201210. 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 Micro Screw System, Micro Screw System Basic?

The Micro Screw System, Micro Screw System Basic is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K201210.

When did The Micro Screw System, Micro Screw System Basic receive FDA 510(k) clearance?

The Micro Screw System, Micro Screw System Basic received FDA 510(k) clearance on 2021-10-08, under 510(k) number K201210.

Who is the listed applicant for The Micro Screw System, Micro Screw System Basic?

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

What is the FDA product code for The Micro Screw System, Micro Screw System Basic?

The FDA product code for The Micro Screw System, Micro Screw System Basic is DZL.

Other records listing Hager& Meisinger 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.

K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)K240321MP Pin flat without thread (36BMP000020/MP20)K173819MyPlant II Implant SystemK180360OKTAGON Implant SystemK170287Dental Implants OKTAGON Bone Level Tapered DesignK162073Dental Implants OKTAGON Tissue Level and Bone Level

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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.

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 GmbHK233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.

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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