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FDA 510(k)

LOQTEQ Proximal Humerus Plate 3.5 System

K-Number: K211582 · 2021-10-18

ApplicantAap Implantate AG
Decision Date2021-10-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOQTEQ Proximal Humerus Plate 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 2021-10-18 under 510(k) number K211582. 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 Proximal Humerus Plate 3.5 System?

LOQTEQ Proximal Humerus Plate 3.5 System is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Aap Implantate AG. The 510(k) number is K211582.

When did LOQTEQ Proximal Humerus Plate 3.5 System receive FDA 510(k) clearance?

LOQTEQ Proximal Humerus Plate 3.5 System received FDA 510(k) clearance on 2021-10-18, under 510(k) number K211582.

Who is the listed applicant for LOQTEQ Proximal Humerus Plate 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 Proximal Humerus Plate 3.5 System?

The FDA product code for LOQTEQ Proximal Humerus Plate 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 ScrewsK230141LOQTEQ® VA Elbow Plates 2.7/3.5 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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