NDN — Cement, Bone, Vertebroplasty Class II
FDA product code NDN covers "Cement, Bone, Vertebroplasty", a Class II medical device regulated under 21 CFR 888.3027. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NDN
- Device Class
- Class II
- Regulation Number
- 888.3027
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251896 | xelite biomed | XeliteMed SuperM-Fix Spinal Bone Cement | January 28, 2026 |
| K250637 | amber implants | VCFix Spinal System | May 30, 2025 |
| K243537 | xelite biomed | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | April 11, 2025 |
| K241775 | xelite biomed | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | September 18, 2024 |
| K232842 | ningbo hicren biotechnology co | Balloon Inflation System | February 29, 2024 |
| K240084 | hyprevention | V-STRUT® Vertebral Implant | February 9, 2024 |
| K231340 | biopsybell | Renova Spine Balloon Catheter | October 30, 2023 |
| K221697 | slk ortho | INJECTION PIN (KIP(02031-02061) (03031-03061)) | March 3, 2023 |
| K223294 | stryker instruments | SpineJack® Expansion Kit | December 20, 2022 |
| K220131 | tecres | KYPHON VuE Bone Cement | April 18, 2022 |
| K211797 | gs medical co | TRACKER Plus Kyphoplasty System | October 28, 2021 |
| K211238 | stryker instruments | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaq | June 25, 2021 |
| K202393 | stryker corporation | SpineJack Expansion Kit | October 20, 2020 |
| K201831 | depuy spine | CONFIDENCE Spinal Cement System | August 31, 2020 |
| K192449 | joline gmbh and co. kg | Joline Kyphoplasty System Allevo | May 27, 2020 |
| K191709 | hyprevention | V-STRUT Vertebral Implant | March 5, 2020 |
| K192335 | gs medical co | TRACKER Kyphoplasty System | December 4, 2019 |
| K192403 | bonwrx | VK100 Percutaneous Vertebral Augmentation System | November 8, 2019 |
| K181262 | vexim | SpineJack Expansion Kit | August 30, 2018 |
| K172871 | hanchang co | SpineKure Kyphoplasty System | May 29, 2018 |