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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, absorbable, orthopaedics, reinforcement of tendon
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Product CodeOWW
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALAFAIR BIOSCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ALAFAIR BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOREZ, INC.
  SUBSTANTIALLY EQUIVALENT 1
CELESTRAY BIOTECH COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
NANOFIBER SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

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