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FDA 510(k)

Anchor plate

K-Number: K173623 · 2018-08-30

ApplicantBiomaterials Korea, Inc.
Decision Date2018-08-30
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Anchor plate is the device name listed in this FDA 510(k) record. The listed applicant is Biomaterials Korea, Inc.. It received FDA 510(k) clearance on 2018-08-30 under 510(k) number K173623. 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 Anchor plate?

Anchor plate is a medical device that received FDA 510(k) clearance on 2018-08-30. The listed applicant is Biomaterials Korea, Inc.. The 510(k) number is K173623.

When did Anchor plate receive FDA 510(k) clearance?

Anchor plate received FDA 510(k) clearance on 2018-08-30, under 510(k) number K173623.

Who is the listed applicant for Anchor plate?

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

What is the FDA product code for Anchor plate?

The FDA product code for Anchor plate is OAT.

Other records listing Biomaterials Korea, Inc. 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.

K222245ACR Screw System

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

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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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