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FDA 510(k)

TDM Large Bone Plate and Screw System

K-Number: K232115 · 2024-04-05

ApplicantTdm Co., Ltd.
Decision Date2024-04-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TDM Large Bone Plate and Screw System is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2024-04-05 under approval number K232115. 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 Large Bone Plate and Screw System?

TDM Large Bone Plate and Screw System is a medical device that received FDA 510(k) clearance on 2024-04-05. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K232115.

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

TDM Large Bone Plate and Screw System received FDA 510(k) clearance on 2024-04-05, under approval number K232115.

What company makes TDM Large Bone Plate and Screw System?

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

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.