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510(k) Data Aggregation
K Number
K083467Device Name
REBOUND HRDV
Manufacturer
MINNESOTA MEDICAL DEVELOPMENT, INC.
Date Cleared
2009-04-23
(150 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MEDICAL DEVELOPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REBOUND HRD® V is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.
Device Description
The REBOUND HRD V (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement directly over the hernia defect so that there is at least 4 cm of circumferential overlap of the hernia defect by the device. The REBOUND HRD V conforms to the anatomy while providing stability. The super-elastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through an appropriately sized access port. It may also be placed via an open incisional approach. The REBOUND HRD V is supplied sterile and is designed as a single use device. It is manufactured in three sizes to accommodate different hernia types, anatomies and surgeon preference.
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K Number
K080393Device Name
MODIFICATION TO REBOUND HRD
Manufacturer
MINNESOTA MEDICAL DEVELOPMENT, INC.
Date Cleared
2008-03-13
(29 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MEDICAL DEVELOPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REBOUND HRD™ is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.
Device Description
The REBOUND HRD™ (Hernia Repair Device) is a self-expanding nitinol framed surgical mesh designed for placement between the fascia and fully closed peritoneum so that it covers the direct and indirect space with at least a 15mm margin beyond the edges of the hernia defect. The REBOUND HRD™ conforms to the anatomy while providing stability; eliminating the need for anchoring. The superelastic multi-stranded nitinol frame allows the device to be folded into a loading cannula (supplied in the product package) and inserted laparoscopically through a 10-12mm access port. It may also be placed via an open incision approach using the same dissection and positioning methods described for the laparoscopic technique. The REBOUND HRD™ is supplied sterile and is designed as a single use device. It is manufactured in several shapes to accommodate different hernia types, anatomies and surgeon preference.
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K Number
K063671Device Name
REBOUND HRD
Manufacturer
MINNESOTA MEDICAL DEVELOPMENT, INC.
Date Cleared
2007-08-16
(248 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MINNESOTA MEDICAL DEVELOPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
REBOUND HRD™ is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.
Device Description
The Rebound HRD™ (Hernia Repair Device) is a self-expanding Nitinol framed/surgical mesh designed for the repair of both inguinal and ventral hernias. The Rebound HRD™ is designed for placement, between the fascia and fully closed peritoneum, so that it covers the direct and indirect space with at least a 15mm margin beyond the edges of the hernia defect. The Rebound HRDTM conforms to the anatomy while providing stability; eliminating the need for anchoring. The super-elastic, multi-strand, Nitinol frame allows the device to be folded into the supplied 10mm loading cannula (supplied in the product package) and inserted laparoscopically through a 10-12mm access port. it may also be placed via an open incision approach using the same dissection and positioning methods described for the laparoscopic technique. The Rebound HRD™ is supplied sterile and is designed as a single use device. It is manufactured in several shapes to accommodate different hernia types, anatomies and surgeon preference.
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