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510(k) Data Aggregation
K Number
K241250Device Name
3DMax Light Mesh
Manufacturer
Davol Inc., Subsidiary of C.R. Bard, Inc.
Date Cleared
2024-06-14
(42 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Davol Inc., Subsidiary of C.R. Bard, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K233402Device Name
Bard 3DMax Mesh
Manufacturer
Davol Inc., Subsidiary of C.R. Bard, Inc.
Date Cleared
2023-11-01
(28 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Davol Inc., Subsidiary of C.R. Bard, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.
Device Description
The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.
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K Number
K191287Device Name
OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
Manufacturer
Davol Inc., Subsidiary of C.R. Bard
Date Cleared
2019-07-16
(64 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
Davol Inc., Subsidiary of C.R. Bard
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
Device Description
The OptiFix™ AT Absorbable Fixation System with Articulating Technology, herein after referred to as "OptiFix™ AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device is available in either 15 or 30 preloaded fasteners. The tip of the shaft can be articulated, and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide and glycolide) and are dyed with D&C Violet No. 2.
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