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 | ||
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Manufacturer | Decision | |
FIBRALIGN CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROTATION MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |