FDA Product Code MBL: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
Leading manufacturers include Microport Orthopedics, Inc..
13
Total
13
Cleared
152d
Avg days
1994
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous Devices (Product Code MBL)
13 devices
About Product Code MBL - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MBL since 1994, with 13 receiving FDA clearance (average review time: 152 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
MBL devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →