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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device u.v. method, cpk isoenzymes
Product CodeJHW
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Osseointegration Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1 1
Implant Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtest Holdings, Inc. III Jun-29-2017
2 Zimmer Biomet, Inc. II Mar-27-2018
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