The FDA granted 510(k) clearance to 10 spine-focused devices in July.
1. Pisces spinal system from Ortho Development
2. SeaSpine spacer system (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura) from SeaSpine Orthopedics
3. Pulse system from NuVasive
4. Ennovate spinal system from Aesculap Implant Systems
5. SureMax-SA cervical standalone system from Additive Implants
6. Zavation spinal system
7. Xvision spine system from Augmedics
8. MySpine WebPlanner and MyBalance from Medacta International
9. StealthStation spinous process clamps from Medtronic Navigation
10. Fixxsure anterior lumbar plate and screw system from Oak Tree Engineering