510(k) clearance
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System
- 510(k) number
- K262646
- Applicant
- Alphatec Spine, Inc.
- Decision date
- Oct 21, 2026
- Date received
- Jul 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MAX
- Device type
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Carlsbad, CA, US