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FDA 510(k)

AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5

K-Number: K132554 · 2013-10-03

ApplicantAap Implantate AG
Decision Date2013-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 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 2013-10-03 under 510(k) number K132554. 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 PROXIMAL MEDIAL TIBIA PLATE 3.5?

AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Aap Implantate AG. The 510(k) number is K132554.

When did AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 receive FDA 510(k) clearance?

AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 received FDA 510(k) clearance on 2013-10-03, under 510(k) number K132554.

Who is the listed applicant for AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5?

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 PROXIMAL MEDIAL TIBIA PLATE 3.5?

The FDA product code for AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 is HRS.

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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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