21 CFR 878.3300 — Mesh, Surgical, Metal

General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3300

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EZXMesh, Surgical, Metal212Implant
FTLMesh, Surgical, Polymeric2335Implant
FTMMesh, Surgical2163Implant
JDJMesh, Surgical, Acetabular, Hip, Prosthesis27Implant
JDKProsthesis, Hip, Cement Restrictor254Implant
LZNCement Obturator237Implant
MCATape, Surgical, Internal21Implant
OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen23Implant
OODSurgical Film213Implant, Life-Sustaining
OQLMesh, Surgical, Deployment Balloon21
ORQMesh, Surgical, Deployer26
OTMMesh, Surgical, For Stress Urinary Incontinence, Male212Implant
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator265Implant
OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed223Implant
OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery21Implant
OWSMesh, Surgical, Collagen, Plastics, Facial Implants20Implant
OWTMesh, Surgical, Absorbable, Abdominal Hernia211Implant
OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia20Implant
OWVMesh, Surgical, Collagen, Diaphragmatic Hernia21Implant
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon210Implant
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon25Implant
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon214Implant
OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction20Implant
OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction20Implant
OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction20Implant
OXCMesh, Surgical, Absorbable, Staple Line Reinforcement29Implant
OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement23Implant
OXEMesh, Surgical, Collagen, Staple Line Reinforcement24Implant
OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery28Implant
OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery20Implant
OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery25Implant
OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects20Implant
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects22Implant
OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects22Implant
OXLMesh, Surgical, Absorbable, Organ Support20Implant
OXMMesh, Surgical, Absorbable, Fistula20Implant
OXNMesh, Surgical, Collagen, Fistula21Implant
PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator29Implant
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling220Implant
PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed22Implant
PIJCollagen Surgical Mesh Containing Drugs23Implant
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament23Implant
QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament21Implant
Innolitics

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