FDA Product Code LDK: Device, Sensing, Optical Contour
Leading manufacturers include Momentum Health, Inc. and Nsite, Inc..
8
Total
8
Cleared
184d
Avg days
1980
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Device, Sensing, Optical Contour Devices (Product Code LDK)
8 devices
Cleared
Nov 15, 2023
NSite Scoliosis Assessment App
Nsite, Inc.
Physical Medicine
267d
Cleared
Oct 04, 2023
Momentum Spine
Momentum Health, Inc.
Physical Medicine
89d
About Product Code LDK - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code LDK since 1980, with 8 receiving FDA clearance (average review time: 184 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LDK devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →