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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spinous process plate
Regulation Description Spinal interlaminal fixation orthosis.
Definition A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Product CodePEK
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
DIO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
KALITEC DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DESIGNS LLC
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 4 4
2020 2 2
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 9 9
Break 3 3
Detachment of Device or Device Component 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Fracture 1 1
Mechanical Problem 1 1
Failure to Disconnect 1 1
Device Handling Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 5 5
Pain 2 2
Insufficient Information 1 1
No Code Available 1 1

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