VK100 Percutaneous Vertebral Augmentation System
FDA 510(k) K192403 · Bonwrx, Ltd.
510(k) numberK192403
Submission
- Device name
- VK100 Percutaneous Vertebral Augmentation System
- Applicant
- Bonwrx, Ltd.
Lansing, MI, US - Received
- September 3, 2019
- Decision date
- November 8, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code NDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone CementNDN · Traditional | Xelite Biomed , Ltd. | 01/28/2026SE |
| K250637 | VCFix Spinal SystemNDN · Traditional | Amber Implants | 05/30/2025SE |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemNDN · Traditional | Xelite Biomed , Ltd. | 04/11/2025SE |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional | Xelite Biomed , Ltd. | 09/18/2024SE |
| K232842 | Balloon Inflation SystemNDN · Traditional | Ningbo Hicren Biotechnology Co., Ltd. | 02/29/2024SE |
| K240084 | V-STRUT® Vertebral ImplantNDN · Special | Hyprevention | 02/09/2024SE |
| K231340 | Renova Spine Balloon CatheterNDN · Traditional | Biopsybell S.R.L. | 10/30/2023SE |
| K221697 | Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional | Slk Ortho, LLC | 03/03/2023SE |
| K223294 | SpineJack® Expansion KitNDN · Traditional | Stryker Instruments | 12/20/2022SE |
| K220131 | KYPHON VuE Bone CementNDN · Traditional | Tecres S.P.A. | 04/18/2022SE |
Questions and answers
When was VK100 Percutaneous Vertebral Augmentation System cleared by the FDA?
VK100 Percutaneous Vertebral Augmentation System (K192403) received a 510(k) decision of Substantially Equivalent on November 8, 2019, 66 days after the submission was received.
What is the product code of K192403?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.