Search Results
Found 1 results
510(k) Data Aggregation
K Number
K082079Device Name
REGEN COLLAGEN SCAFFOLD (CS)
Manufacturer
REGEN BIOLOGICS, INC.
Date Cleared
2008-12-18
(148 days)
Product Code
OLC
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
REGEN BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair 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 for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.
Device Description
The ReGen Collagen Scaffold (CS) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CS is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue.
Ask a Question
Page 1 of 1