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FDA 510(k)

ATOZ Mini-Screw

K-Number: K210559 · 2021-12-19

ApplicantMk Meditech, Inc.
Decision Date2021-12-19
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATOZ Mini-Screw is the device name listed in this FDA 510(k) record. The listed applicant is Mk Meditech, Inc.. It received FDA 510(k) clearance on 2021-12-19 under 510(k) number K210559. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATOZ Mini-Screw?

ATOZ Mini-Screw is a medical device that received FDA 510(k) clearance on 2021-12-19. The listed applicant is Mk Meditech, Inc.. The 510(k) number is K210559.

When did ATOZ Mini-Screw receive FDA 510(k) clearance?

ATOZ Mini-Screw received FDA 510(k) clearance on 2021-12-19, under 510(k) number K210559.

Who is the listed applicant for ATOZ Mini-Screw?

The FDA 510(k) record lists Mk Meditech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATOZ Mini-Screw?

The FDA product code for ATOZ Mini-Screw is OAT.

Related Devices (Code: OAT)

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.

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.

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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