FDA Product Code KYJ: Prosthesis, Finger, Constrained, Polymer
Leading manufacturers include Ascension Orthopedics, Inc..
14
Total
14
Cleared
206d
Avg days
1978
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Prosthesis, Finger, Constrained, Polymer Devices (Product Code KYJ)
14 devices
About Product Code KYJ - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code KYJ since 1978, with 14 receiving FDA clearance (average review time: 206 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
KYJ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →