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FDA 510(k)

ACR Screw System

K-Number: K222245 · 2023-08-21

ApplicantBiomaterials Korea, Inc.
Decision Date2023-08-21
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACR Screw System 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 2023-08-21 under 510(k) number K222245. 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 ACR Screw System?

ACR Screw System is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Biomaterials Korea, Inc.. The 510(k) number is K222245.

When did ACR Screw System receive FDA 510(k) clearance?

ACR Screw System received FDA 510(k) clearance on 2023-08-21, under 510(k) number K222245.

Who is the listed applicant for ACR Screw System?

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 ACR Screw System?

The FDA product code for ACR Screw System 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.

K173623Anchor plate

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.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.K202691Ortholock Anchorage DevicesCraniofacial Technologies, Inc.

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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