LZY · Class II · 21 CFR 888.3360

FDA Product Code LZY: Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Leading manufacturers include Smith & Nephew, Inc..

8
Total
8
Cleared
145d
Avg days
1989
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prosthesis, Hip, Hemi-, Femoral, Metal Ball Devices (Product Code LZY)

8 devices
1–8 of 8

About Product Code LZY - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code LZY since 1989, with 8 receiving FDA clearance (average review time: 145 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

LZY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →