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FDA 510(k)

TDM Plate and Screw System

K-Number: K241128 · 2024-12-05

ApplicantTdm Co., Ltd.
Decision Date2024-12-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TDM Plate and Screw System is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2024-12-05 under approval number K241128. 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 TDM Plate and Screw System?

TDM Plate and Screw System is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K241128.

When was TDM Plate and Screw System approved by the FDA?

TDM Plate and Screw System received FDA 510(k) clearance on 2024-12-05, under approval number K241128.

What company makes TDM Plate and Screw System?

TDM Plate and Screw System is manufactured by Tdm Co., Ltd..

What is the FDA product code for TDM Plate and Screw System?

The FDA product code for TDM Plate and Screw System is HRS.

Related Clinical Trials

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Other Devices by Tdm Co., Ltd.

K171808TDM Plate and Screw System K190391TDM Plate and Screw Systems K190830TDM Screw Systems K191057Park's Pectus System K221844TDM Lumbar Interbody Fusion Cage System K220285PINE Pedicle Screw System

View all 11 devices →

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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