Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

Device Code: 5846

Product Code(s): OXH

Definition: For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.

Device Classification Information

Device Type ID5846
Device NameMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Physical StateA Collagen Mesh; Either Square, Rectangular, Round Or Of Various Other Shapes.
Technical MethodA Collagen Mesh That Reinforces Soft Tissue
Target AreaAreas In Need Of Plastic And Reconstructive Surgery
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 CodeOXH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5846
DeviceMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Product CodeOXH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
Premarket Reviews
ManufacturerDecision
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
TPLC Last Update: 2019-04-02 21:13:19

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