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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intraoperative orthopedic joint assessment aid
Definition Measurement and interpretation of orthopedic joint information.
Product CodeONN
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
KAMM & ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 8
SYNVASIVE TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
THESE THREE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
XPANDORTHO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Orthosensor II Oct-24-2012
2 Orthosensor, Inc. II Oct-05-2018
3 Orthosensor, Inc. II Jan-29-2015
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