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510(k) K191057

Park's Pectus System by Tdm Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2020
Date Received
April 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K232115 — TDM Large Bone Plate and Screw System (April 5, 2024)
  • K231860 — TDM Screw System (January 18, 2024)
  • K221844 — TDM Lumbar Interbody Fusion Cage System (August 17, 2022)
  • K220285 — PINE Pedicle Screw System (May 19, 2022)
  • 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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