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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
Regulation Description Stereotaxic instrument.
Definition Measurement and interpretation of orthopedic joint information.
Product CodeONN
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K150372  VERASENSE Knee System
  2.  K180459  VERASENSE for Zimmer Biomet Persona
  3.  K193580  VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef ...
  4.  K200587  VERASENSE for Exactech Equinoxe Size 38 mm, VERASE ...
  5.  K200665  VERASENSE for Stryker Triathlon
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, Inc. II Oct-05-2018
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