Spinal Simplicity is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spinal Simplicity - FDA 510(k) Cleared Devices
Recent clearances: Freedom DS™ Decompression System
2
Total
2
Cleared
0
Denied
Spinal Simplicity, is a medical device company dedicated to creating innovative procedure solutions for spinal and orthopedic surgery. Based in Overland Park, Kansas, the company develops implants and instrumentation designed to improve patient outcomes and reduce procedural complexity.
The company has received 2 FDA 510(k) clearances from 2 total submissions, with 100% focused on Orthopedic devices. Spinal Simplicity achieved its first FDA clearance in 2017 and remains active, with the most recent clearance in 2026. The company specializes in minimally invasive spinal fusion technologies, including posterior instrumentation systems and sacroiliac joint fusion devices.
Founded in 2008 by neurosurgeon Dr. Harold Hess and orthopedic entrepreneur Todd Moseley, Spinal Simplicity holds over 150 patents globally and maintains ISO 13485 certification. The company's product portfolio spans lumbar fusion, sacroiliac joint stabilization, and cervical spine solutions, all manufactured in the United States.
Explore the company's cleared device names, product codes, and clearance dates in the database below.
FDA 510(k) Regulatory Record - Spinal Simplicity
2 devices