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FDA 510(k)

Membrane Screws and Membrane Tacks

K-Number: K201561 · 2020-10-05

ApplicantNeoss Limited
Decision Date2020-10-05
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Membrane Screws and Membrane Tacks is the device name listed in this FDA 510(k) record. The listed applicant is Neoss Limited. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K201561. 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 Membrane Screws and Membrane Tacks?

Membrane Screws and Membrane Tacks is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Neoss Limited. The 510(k) number is K201561.

When did Membrane Screws and Membrane Tacks receive FDA 510(k) clearance?

Membrane Screws and Membrane Tacks received FDA 510(k) clearance on 2020-10-05, under 510(k) number K201561.

Who is the listed applicant for Membrane Screws and Membrane Tacks?

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

What is the FDA product code for Membrane Screws and Membrane Tacks?

The FDA product code for Membrane Screws and Membrane Tacks is DZL.

Other records listing Neoss Limited 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.

K211396Neoss Individual Prosthetics

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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