Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction

Device Code: 5840

Product Code(s): OXB

Definition: For Reinforcement Of Soft Tissue Where Weakness Exists During Chest Wall Reconstruction.

Device Classification Information

Device Type ID5840
Device NameMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
Physical StateA Collagen Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes.
Technical MethodA Collagen Mesh That Reinforces Soft Tissue
Target AreaChest Wall
Regulation DescriptionSurgical Mesh.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type510(k)
CFR Regulation Number878.3300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOXB
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5840
DeviceMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
Product CodeOXB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
Device Problems
Degraded
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:13:14

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