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510(k) K240423

TDM Anterior Cervical Plate System by Tdm Co., Ltd. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2024
Date Received
February 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K190391 — TDM Plate and Screw Systems (November 15, 2019)
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