Device type
Intervertebral Fusion Device With Bone Graft, Lumbar
Product code MAX · Class II · 21 CFR 888.3080 · Orthopedic
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Recent 510(k)s
Oct 29, 2026
K262572
Symmetrix™ PX Spinal System
Medtronic Sofamor Danek USA, Inc.
- MAX
- Class II
Oct 21, 2026
K262646
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System
Alphatec Spine, Inc.
- MAX
- Class II
Aug 20, 2026
K261049
SCALA® TL
Spineart SA
- MAX
- Class II
Recent recalls
No recalls in the archive for MAX.