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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
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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New Search show TPLC since Back to Search Results
Device stimulator, invasive bone growth
Product CodeLOE
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
4 4 4 16 4 0

Device Problems
Insufficient Information 10
Appropriate Term/Code Not Available 6
Patient-Device Incompatibility 3
Failure to Power Up 2
Migration or Expulsion of Device 1
Detachment of Device or Device Component 1
Adverse Event Without Identified Device or Use Problem 1
Disconnection 1
Migration 1
Material Discolored 1
Total Device Problems 27

Recalls
Manufacturer Recall Class Date Posted
1 EBI Patient Care, Inc. I May-26-2017
2 Zimmer Biomet, Inc. I Nov-02-2018

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