Definition: For Reinforcement Of Soft Tissue Where Weakness Exists In Tendon Repair.
| Device Type ID | 5837 |
| Device Name | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| 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 | Tendon |
| 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 | OWY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5837 |
| Device | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| Product Code | OWY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FIBRALIGN CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROTATION MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |