FDA Product Code LXM: Manipulator, Plunger-like Joint
Leading manufacturers include Spinalight, Inc., Optima Health Solutions International Corp. and Neuro Spinal Innovation, Inc..
32
Total
32
Cleared
189d
Avg days
1988
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Manipulator, Plunger-like Joint Devices (Product Code LXM)
32 devices
Cleared
Feb 15, 2024
SONIK MONARK 100
Neuro Spinal Innovation, Inc.
Physical Medicine
56d
Cleared
Dec 21, 2019
Spinalytics
Optima Health Solutions International Corp.
Neurology
89d
Cleared
Jun 20, 2018
Atlas Percussion Adjusting Instrument
Spinalight, Inc.
Physical Medicine
302d
About Product Code LXM - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code LXM since 1988, with 32 receiving FDA clearance (average review time: 189 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.