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510(k) K231860

TDM Screw System by Tdm Co., Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2024
Date Received
June 23, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Tdm Co., Ltd.

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  • K240423 — TDM Anterior Cervical Plate System (April 8, 2024)
  • K232115 — TDM Large Bone Plate and Screw System (April 5, 2024)
  • K221844 — TDM Lumbar Interbody Fusion Cage System (August 17, 2022)
  • K220285 — PINE Pedicle Screw System (May 19, 2022)
  • K191057 — Park's Pectus System (March 19, 2020)
  • K190391 — TDM Plate and Screw Systems (November 15, 2019)
  • K190830 — TDM Screw Systems (September 13, 2019)
  • K171808 — TDM Plate and Screw System (March 15, 2018)

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