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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen
Regulation Description Surgical mesh.
Definition Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patients own soft tissue. The device is not a prosthetic device and is not intended to replace normal body structure.
Product CodeOLC
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1

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