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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, facet screw spinal device
Product CodeMRW
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 3
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZYGOFIX LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Migration 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA, Inc II Jun-04-2021
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