FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
K Number: K243537
·
Decision Apr 11, 2025
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
3
Review Days
147
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
- K Number
- K243537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xelite Biomed , Ltd.
- Date Received
- November 15, 2024
- Decision Date
- April 11, 2025
- Product Code
- NDN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NDN), ordered by most recent decision date.
XeliteMed SuperM-Fix Spinal Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
VCFix Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
Balloon Inflation System
FDA 510(k)
FDA Class 2
·Orthopedic
V-STRUT® Vertebral Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Renova Spine Balloon Catheter
FDA 510(k)
FDA Class 2
·Orthopedic