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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone fixation cerclage, sublaminar
Regulation Description Bone fixation cerclage.
Definition Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Product CodeOWI
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
COUSIN BIOTECH S.A.S.
  SUBSTANTIALLY EQUIVALENT 2
GLOBE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET S.A.
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 7
Adverse Event Without Identified Device or Use Problem 3
Naturally Worn 2
Fracture 2
Loosening of Implant Not Related to Bone-Ingrowth 2
Mechanical Problem 1
Output above Specifications 1
Improper or Incorrect Procedure or Method 1
Device Operates Differently Than Expected 1
Fastener 1
No Apparent Adverse Event 1
Appropriate Term/Code Not Available 1
Total Device Problems 23

Recalls
Manufacturer Recall Class Date Posted
1 OrthoPediatrics Corp II Jun-09-2017

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