Mesh, Surgical, Non-absorbable, Thoracic, Chest Wall Reconstruction

Device Code: 5839

Product Code(s): OXA

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

Device Classification Information

Device Type ID5839
Device NameMesh, Surgical, Non-absorbable, Thoracic, Chest Wall Reconstruction
Physical StateA Non-absorbable Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes.
Technical MethodA Non-absorbable 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 CodeOXA
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5839
DeviceMesh, Surgical, Non-absorbable, Thoracic, Chest Wall Reconstruction
Product CodeOXA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
TPLC Last Update: 2019-04-02 21:13:13

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