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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device resorbable implant for anterior cruciate ligament (acl) repair
Definition A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.
Product CodeQNI
Regulation Number 888.3044
Device Class 2


Premarket Reviews
ManufacturerDecision
MIACH ORTHOPAEDICS, INC.
  GRANTED 1

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