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FDA 510(k)

aap LOQTEQ VA Radius Set 2.5

K-Number: K153034 · 2016-01-21

ApplicantAap Implantate AG
Decision Date2016-01-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

aap LOQTEQ VA Radius Set 2.5 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 2016-01-21 under 510(k) number K153034. 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 aap LOQTEQ VA Radius Set 2.5?

aap LOQTEQ VA Radius Set 2.5 is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Aap Implantate AG. The 510(k) number is K153034.

When did aap LOQTEQ VA Radius Set 2.5 receive FDA 510(k) clearance?

aap LOQTEQ VA Radius Set 2.5 received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153034.

Who is the listed applicant for aap LOQTEQ VA Radius Set 2.5?

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 aap LOQTEQ VA Radius Set 2.5?

The FDA product code for aap LOQTEQ VA Radius Set 2.5 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.

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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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