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FDA 510(k)

BIO-RAY A-1 Anchor Screw System

K-Number: K182929 · 2019-11-06

ApplicantMicroware Precision Co., Ltd.
Decision Date2019-11-06
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-RAY A-1 Anchor Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K182929. 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 BIO-RAY A-1 Anchor Screw System?

BIO-RAY A-1 Anchor Screw System is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K182929.

When did BIO-RAY A-1 Anchor Screw System receive FDA 510(k) clearance?

BIO-RAY A-1 Anchor Screw System received FDA 510(k) clearance on 2019-11-06, under 510(k) number K182929.

Who is the listed applicant for BIO-RAY A-1 Anchor Screw System?

The FDA 510(k) record lists Microware Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-RAY A-1 Anchor Screw System?

The FDA product code for BIO-RAY A-1 Anchor Screw System is OAT.

Other records listing Microware Precision Co., Ltd. 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.

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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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