Renova Spine Balloon Catheter
FDA 510(k) K231340 · Biopsybell S.R.L.
510(k) numberK231340
Submission
- Device name
- Renova Spine Balloon Catheter
- Applicant
- Biopsybell S.R.L.
Mirandola, IT - Received
- May 9, 2023
- Decision date
- October 30, 2023
- 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
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|---|---|---|---|
| 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 |
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| 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 |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | GS Medical Co., Ltd. | 10/28/2021SE |
More from GS Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…KNW · Traditional | 01/11/2021SE |
| K180315 | DiskomHRX · Traditional | 03/26/2018SE |
| K130616 | Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesKNW · Traditional | 02/07/2014SE |
Questions and answers
When was Renova Spine Balloon Catheter cleared by the FDA?
Renova Spine Balloon Catheter (K231340) received a 510(k) decision of Substantially Equivalent on October 30, 2023, 174 days after the submission was received.
What is the product code of K231340?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.