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FDA 510(k)

TDM Plate and Screw Systems

K-Number: K190391 · 2019-11-15

ApplicantTdm Co., Ltd.
Decision Date2019-11-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TDM Plate and Screw Systems is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2019-11-15 under approval number K190391. 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 Systems?

TDM Plate and Screw Systems is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K190391.

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

TDM Plate and Screw Systems received FDA 510(k) clearance on 2019-11-15, under approval number K190391.

What company makes TDM Plate and Screw Systems?

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

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

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

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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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