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FDA 510(k)

Tandry Locking Plate System

K-Number: K171904 · 2018-09-18

ApplicantMicroware Precision Co., Ltd.
Decision Date2018-09-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tandry Locking Plate System is a medical device manufactured by Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2018-09-18 under approval number K171904. 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 Locking Plate System?

Tandry Locking Plate System is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Microware Precision Co., Ltd.. The 510(k) number is K171904.

When was Tandry Locking Plate System approved by the FDA?

Tandry Locking Plate System received FDA 510(k) clearance on 2018-09-18, under approval number K171904.

What company makes Tandry Locking Plate System?

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

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

The FDA product code for Tandry 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.

K182929BIO-RAY A-1 Anchor Screw System K220360Tandry CMF Plate System K220359Tandry Compression Screw System K230690Tandry Locking Plate System K242814Tandry Q-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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