FWP · Class II · 21 CFR 878.3550

FDA Product Code FWP: Prosthesis, Chin, Internal

Leading manufacturers include Stryker Leibinger GmbH & Co KG.

66
Total
66
Cleared
98d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 73d recently vs 98d historically

FDA 510(k) Cleared Prosthesis, Chin, Internal Devices (Product Code FWP)

66 devices
1–24 of 66

About Product Code FWP - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code FWP since 1976, with 66 receiving FDA clearance (average review time: 98 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA Review Time

Recent submissions under FWP have taken an average of 73 days to reach a decision - down from 98 days historically, suggesting improved FDA processing for this classification.

FWP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →