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FDA 510(k)

ATR 5000, LC 5000, IMPLANT SYSTEM

K-Number: K033597 · 2003-11-25

ApplicantAdvanced Technology Research (A.T.R.) S.R.L.
Decision Date2003-11-25
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATR 5000, LC 5000, IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Research (A.T.R.) S.R.L.. It received FDA 510(k) clearance on 2003-11-25 under 510(k) number K033597. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATR 5000, LC 5000, IMPLANT SYSTEM?

ATR 5000, LC 5000, IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-25. The listed applicant is Advanced Technology Research (A.T.R.) S.R.L.. The 510(k) number is K033597.

When did ATR 5000, LC 5000, IMPLANT SYSTEM receive FDA 510(k) clearance?

ATR 5000, LC 5000, IMPLANT SYSTEM received FDA 510(k) clearance on 2003-11-25, under 510(k) number K033597.

Who is the listed applicant for ATR 5000, LC 5000, IMPLANT SYSTEM?

The FDA 510(k) record lists Advanced Technology Research (A.T.R.) S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATR 5000, LC 5000, IMPLANT SYSTEM?

The FDA product code for ATR 5000, LC 5000, IMPLANT SYSTEM is EKX.

Related Clinical Trials

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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Other records listing Advanced Technology Research (A.T.R.) S.R.L. 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.

K243692EnDrive (EnDriveUS)

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis 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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