FDA Product Code LOF: Stimulator, Bone Growth, Non-invasive
Leading manufacturers include Djo, LLC and Ethicon, Inc..
2
Total
2
Cleared
46d
Avg days
1982
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
60d
recently vs 32d historically
FDA 510(k) Cleared Stimulator, Bone Growth, Non-invasive Devices (Product Code LOF)
2 devices
Cleared
Sep 29, 2026
Spinalogic Bone Growth Stimulator
Djo, LLC
Orthopedic
60d
Cleared
Aug 24, 1982
ETHICON TEMPORARY CARDIAC PACING WIRE
Ethicon, Inc.
Orthopedic
32d
About Product Code LOF - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code LOF since 1982, with 2 receiving FDA clearance (average review time: 46 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LOF Product Code
Recent submissions under LOF have taken an average of 60 days to reach a decision - up from 32 days historically. Manufacturers should account for longer review timelines in current project planning.
LOF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →