Prosthesis, Nose, Internal

Device Code: 5566

Product Code(s): FZE

Device Classification Information

• Device Type ID: 5566
• Device Name: Prosthesis, Nose, Internal
• Regulation Description: Nose Prosthesis.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: 510(k)
• CFR Regulation Number: 878.3680 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FZE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-179 ASTM F754-08 (Reapproved 2015)
  Standard Specification For Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, And Rod Shapes Fabricated From Granular Molding Powders

Total Product Life Cycle

• Device Type ID: 5566
• Device: Prosthesis, Nose, Internal
• Product Code: FZE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nose Prosthesis.
• CFR Regulation Number: 878.3680 [🔎]

Device Problems
Appropriate Term/Code Not Available	16
Loss Of Osseointegration	15
Insufficient Information	1
Osseointegration Problem	1
Total Device Problems	33

TPLC Last Update: 2019-04-02 21:08:34