Part 878 Subpart D—Prosthetic Devices

FDA submissions for Part 878 Subpart D—Prosthetic Devices in the General, Plastic Surgery (SU) review panel, including product codes and regulations.

Section range: §§ 878.3250–878.3925

CFR Part: 878

Product Codes

Product CodeDevice NameRegulationClassDevices
FYIAppliance, Facial Fracture, External878.325014
EZXMesh, Surgical, Metal878.3300212
FTLMesh, Surgical, Polymeric878.33002335
FTMMesh, Surgical878.33002163
JDJMesh, Surgical, Acetabular, Hip, Prosthesis878.330027
JDKProsthesis, Hip, Cement Restrictor878.3300254
LZNCement Obturator878.3300237
MCATape, Surgical, Internal878.330021
OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen878.330023
OODSurgical Film878.3300213
OQLMesh, Surgical, Deployment Balloon878.330021
ORQMesh, Surgical, Deployer878.330026
OTMMesh, Surgical, For Stress Urinary Incontinence, Male878.3300212
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator878.3300265
OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed878.3300223
OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery878.330021
OWSMesh, Surgical, Collagen, Plastics, Facial Implants878.330020
OWTMesh, Surgical, Absorbable, Abdominal Hernia878.3300211
OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia878.330020
OWVMesh, Surgical, Collagen, Diaphragmatic Hernia878.330021
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon878.3300210
OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon878.330025
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon878.3300214
OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction878.330020
OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction878.330020
OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction878.330020
OXCMesh, Surgical, Absorbable, Staple Line Reinforcement878.330029
OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement878.330023
OXEMesh, Surgical, Collagen, Staple Line Reinforcement878.330024
OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery878.330028
OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery878.330020
OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery878.330025
OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects878.330020
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects878.330022
OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects878.330022
OXLMesh, Surgical, Absorbable, Organ Support878.330020
OXMMesh, Surgical, Absorbable, Fistula878.330020
OXNMesh, Surgical, Collagen, Fistula878.330021
PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator878.330029
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling878.3300220
PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed878.330022
PIJCollagen Surgical Mesh Containing Drugs878.330023
QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament878.330023
QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament878.330021
ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent878.350022
KDAProsthesis, Ptfe/Carbon-Fiber878.350021
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction878.3500225
ODUFacial Implant878.350021
PQNCarbon Dioxide Gas Controlled Tissue Expander878.351023
FWMProsthesis, Breast, Inflatable, Internal, Saline878.353033
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled878.354036
FWPProsthesis, Chin, Internal878.3550266
LZKImplant, Malar878.3550240
MNFImplant, Temporal878.355022
FZDProsthesis, Ear, Internal878.359023
ESWProsthesis, Esophageal878.3610259
JCQProsthesis, Esophagus878.361021
MQRStent, Colonic, Metallic, Expandable878.3610216
MUMStent, Metallic, Expandable, Duodenal878.361026
FZEProsthesis, Nose, Internal878.3680242
JCTProsthesis, Tracheal, Expandable878.3720245
NWAProsthesis, Tracheal, Preformed/Molded878.372026
NYTProsthesis, Tracheal, Expandable, Polymeric878.372023
GBJProsthesis, Adhesive, External878.375014
GBIMaterial, External Aesthetic Restoration, Used With Adhesive878.3800117
KCZProsthesis, Breast, External, Used With Adhesive878.3800113
NOJProsthesis, Breast, External, No Adhesive878.380010
NOKMaterial, External Aesthetic Restoration, No Adhesive878.380010
FZFSplint, Extremity, Inflatable, External878.390017
BTXBoard, Arm (With Cover), Sterile878.3910113
FYHSplint, Extremity, Noninflatable, External, Sterile878.391018
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile878.391010
NODBoard, Arm (With Cover), Non-Sterile878.391010
FTNPlastic Surgery And Accessories Kit878.392510
Innolitics

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