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FDA 510(k)

APTUS® 3.5 TriLock Straight Plates

K-Number: K230971 · 2023-06-02

ApplicantMedartis AG
Decision Date2023-06-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS® 3.5 TriLock Straight Plates is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2023-06-02 under approval number K230971. 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 APTUS® 3.5 TriLock Straight Plates?

APTUS® 3.5 TriLock Straight Plates is a medical device that received FDA 510(k) clearance on 2023-06-02. It is manufactured by Medartis AG. The 510(k) number is K230971.

When was APTUS® 3.5 TriLock Straight Plates approved by the FDA?

APTUS® 3.5 TriLock Straight Plates received FDA 510(k) clearance on 2023-06-02, under approval number K230971.

What company makes APTUS® 3.5 TriLock Straight Plates?

APTUS® 3.5 TriLock Straight Plates is manufactured by Medartis AG.

What is the FDA product code for APTUS® 3.5 TriLock Straight Plates?

The FDA product code for APTUS® 3.5 TriLock Straight Plates is HRS.

Other Devices by Medartis AG

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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