Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TDM Anterior Cervical Plate System

K-Number: K240423 · 2024-04-08

ApplicantTdm Co., Ltd.
Decision Date2024-04-08
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TDM Anterior Cervical Plate 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 2024-04-08 under 510(k) number K240423. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDM Anterior Cervical Plate System?

TDM Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-04-08. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K240423.

When did TDM Anterior Cervical Plate System receive FDA 510(k) clearance?

TDM Anterior Cervical Plate System received FDA 510(k) clearance on 2024-04-08, under 510(k) number K240423.

Who is the listed applicant for TDM Anterior Cervical Plate 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 Anterior Cervical Plate System?

The FDA product code for TDM Anterior Cervical Plate System is KWQ.

Related Clinical Trials

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

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 SystemK232115TDM Large Bone Plate and Screw SystemK231860TDM Screw SystemK221844TDM Lumbar Interbody Fusion Cage SystemK220285PINE Pedicle Screw System

View all 11 devices →

Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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.

↑