Definition: For Reinforcement Of Soft Tissue Where Weakness Exists During Chest Wall Reconstruction.
Device Type ID | 5839 |
Device Name | Mesh, Surgical, Non-absorbable, Thoracic, Chest Wall Reconstruction |
Physical State | A Non-absorbable Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes. |
Technical Method | A Non-absorbable Mesh That Reinforces Soft Tissue |
Target Area | Chest Wall |
Regulation Description | Surgical Mesh. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & 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 Type | 510(k) |
CFR Regulation Number | 878.3300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | OXA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5839 |
Device | Mesh, Surgical, Non-absorbable, Thoracic, Chest Wall Reconstruction |
Product Code | OXA |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Surgical Mesh. |
CFR Regulation Number | 878.3300 [🔎] |