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FDA 510(k)

LOQTEQ® VA Elbow Plates 2.7/3.5 System

K-Number: K230141 · 2023-03-17

ApplicantAap Implantate AG
Decision Date2023-03-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOQTEQ® VA Elbow Plates 2.7/3.5 System is the device name listed in this FDA 510(k) record. The listed applicant is Aap Implantate AG. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K230141. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOQTEQ® VA Elbow Plates 2.7/3.5 System?

LOQTEQ® VA Elbow Plates 2.7/3.5 System is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Aap Implantate AG. The 510(k) number is K230141.

When did LOQTEQ® VA Elbow Plates 2.7/3.5 System receive FDA 510(k) clearance?

LOQTEQ® VA Elbow Plates 2.7/3.5 System received FDA 510(k) clearance on 2023-03-17, under 510(k) number K230141.

Who is the listed applicant for LOQTEQ® VA Elbow Plates 2.7/3.5 System?

The FDA 510(k) record lists Aap Implantate AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOQTEQ® VA Elbow Plates 2.7/3.5 System?

The FDA product code for LOQTEQ® VA Elbow Plates 2.7/3.5 System is HRS.

Other records listing Aap Implantate AG 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.

K254253LOQTEQ® VA Proximal Humerus Plate 3.5K233008Cannulated Headless Bone ScrewsK211582LOQTEQ Proximal Humerus Plate 3.5 SystemK210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemK182818LOQTEQ VA Calcaneus Plate 3.5K182785LOQTEQ VA Foot Plates 2.5

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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