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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, external fixator (with metallic invasive components)
Product CodeNDK
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
3D MEDICAL CONCEPTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHRISTOPHER D. ENDARA
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Loss of Range of Motion 1 1
Tissue Damage 1 1
Post Operative Wound Infection 1 1
Failure of Implant 1 1

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