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FDA 510(k)

Tandry Q-Locking Plate System

K-Number: K242814 · 2024-11-14

ApplicantMicroware Precision Co., Ltd.
Decision Date2024-11-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tandry Q-Locking Plate System is a medical device manufactured by Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2024-11-14 under approval number K242814. 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 Tandry Q-Locking Plate System?

Tandry Q-Locking Plate System is a medical device that received FDA 510(k) clearance on 2024-11-14. It is manufactured by Microware Precision Co., Ltd.. The 510(k) number is K242814.

When was Tandry Q-Locking Plate System approved by the FDA?

Tandry Q-Locking Plate System received FDA 510(k) clearance on 2024-11-14, under approval number K242814.

What company makes Tandry Q-Locking Plate System?

Tandry Q-Locking Plate System is manufactured by Microware Precision Co., Ltd..

What is the FDA product code for Tandry Q-Locking Plate System?

The FDA product code for Tandry Q-Locking Plate System is HRS.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Microware Precision Co., Ltd.

K171904Tandry Locking Plate System K182929BIO-RAY A-1 Anchor Screw System K220360Tandry CMF Plate System K220359Tandry Compression Screw System K230690Tandry Locking Plate System

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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