NDN
- Product code
- NDN
- Device name
- Cement, Bone, Vertebroplasty
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3027
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 108 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251896 | 2026-01-28 | Xelite Biomed , Ltd. | XeliteMed SuperM-Fix Spinal Bone Cement | |
| K250637 | 2025-05-30 | Amber Implants | VCFix Spinal System | |
| K243537 | 2025-04-11 | Xelite Biomed , Ltd. | XeliteMed VertehighFix High Viscosity Spinal Bone Ce… | |
| K241775 | 2024-09-18 | Xelite Biomed , Ltd. | XeliteMed VertehighFix High Viscosity Spinal Bone Ce… | |
| K232842 | 2024-02-29 | Ningbo Hicren Biotechnology Co., Ltd. | Balloon Inflation System | |
| K240084 | 2024-02-09 | Hyprevention | V-STRUT® Vertebral Implant | |
| K231340 | 2023-10-30 | Biopsybell S.R.L. | Renova Spine Balloon Catheter |
Official FDA classification page: NDN
Classification and pathway per current FDA publications. Data from openFDA (CC0).