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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed
Definition A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
Product CodeQPQ
Regulation Number 888.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHO-SPACE LTD.
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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