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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device manual instruments designed for use with total disc replacement devices
Definition The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Product CodeQLQ
Regulation Number 888.4515
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANTS SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
CENTINEL SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL KINETICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1
Device Damaged by Another Device 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Injury 1 1

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