Definition: For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
Device Type ID | 5846 |
Device Name | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
Physical State | A Collagen Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes. |
Technical Method | A Collagen Mesh That Reinforces Soft Tissue |
Target Area | Areas In Need Of Plastic And Reconstructive Surgery |
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 | OXH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5846 |
Device | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
Product Code | OXH |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Surgical Mesh. |
CFR Regulation Number | 878.3300 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
MIROMATRIX MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 15 |
Degraded | 1 |
Use Of Device Problem | 1 |
Material Split, Cut Or Torn | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Insufficient Information | 1 |
Total Device Problems | 20 |