FDA Product Code KWD: Prosthesis, Toe, Hemi-, Phalangeal
Leading manufacturers include Accufix Surgical, Inc..
45
Total
45
Cleared
145d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 4 in the prior period
FDA 510(k) Cleared Prosthesis, Toe, Hemi-, Phalangeal Devices (Product Code KWD)
45 devices
About Product Code KWD - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code KWD since 1979, with 45 receiving FDA clearance (average review time: 145 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.
KWD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →