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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device filler, bone void, osteoinduction (w/o human growth factor)
Regulation Description Resorbable calcium salt bone void filler device.
Product CodeMBP
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
VIVORTE, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Labelling, Instructions for Use or Training Problem 3
Device Markings / Labelling Problem 3
Adverse Event Without Identified Device or Use Problem 3
Inaccurate Information 3
Shelf Life Exceeded 2
Shipping Damage or Problem 1
Use of Device Problem 1
Inaudible or Unclear Audible Prompt / Feedback 1
Patient-Device Incompatibility 1
Device Handling Problem 1
Total Device Problems 19

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Jun-25-2014
2 Medtronic Sofamor Danek USA Inc II Feb-12-2014
3 Musculoskeletal Transplant Foundation, Inc. II Jun-16-2016

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