Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Device Code: 5835

Product Code(s): OWW

Definition: For Reinforcement Of Soft Tissue Where Weakness Exists During Tendon Repair Procedures.

Device Classification Information

Device Type ID5835
Device NameMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Physical StateAn Absorbable Mesh; Either Square, Rectangular, Round Or Of Other Various Shapes
Technical MethodAn Absorbable Mesh That Reinforces Soft Tissue
Target AreaTendon
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 CodeOWW
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5835
DeviceMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Product CodeOWW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
TPLC Last Update: 2019-04-02 21:13:08

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