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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 the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) 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. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K232115.

When did TDM Large Bone Plate and Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for TDM Large Bone Plate and Screw System?

The FDA 510(k) record lists Tdm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Tdm Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241128TDM Plate and Screw SystemK230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail SystemK240423TDM Anterior Cervical Plate SystemK231860TDM Screw SystemK221844TDM Lumbar Interbody Fusion Cage SystemK220285PINE Pedicle Screw System

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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