FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
XeliteMed SuperM-Fix Spinal Bone Cement
K Number: K251896
·
Decision Jan 28, 2026
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
107
Applicant Total
3
Review Days
222
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Basic Information
- Device Name
- XeliteMed SuperM-Fix Spinal Bone Cement
- K Number
- K251896
- 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
- June 20, 2025
- Decision Date
- January 28, 2026
- 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 |
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