510(k) clearance
VariLift-C Cervical Interbody Fusion System
- 510(k) number
- K262595
- Applicant
- Wenzel Spine, Inc.
- Decision date
- Aug 26, 2026
- Date received
- Jul 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- ODP
- Device type
- Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Austin, TX, US