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FDA 510(k)

LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE

K-Number: K132787 · 2013-12-24

ApplicantAap Implantate AG
Decision Date2013-12-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE 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 2013-12-24 under 510(k) number K132787. 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 DISTAL DORSOLATERAL HUMERUS PLATE?

LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE is a medical device that received FDA 510(k) clearance on 2013-12-24. The listed applicant is Aap Implantate AG. The 510(k) number is K132787.

When did LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE receive FDA 510(k) clearance?

LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE received FDA 510(k) clearance on 2013-12-24, under 510(k) number K132787.

Who is the listed applicant for LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE?

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 DISTAL DORSOLATERAL HUMERUS PLATE?

The FDA product code for LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE is HRS.

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Other records listing Aap Implantate AG as applicant

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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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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