Kiva VCF Treatment System
FDA 510(k) K141141 · Benvenue Medical, Inc.
510(k) numberK141141
Submission
- Device name
- Kiva VCF Treatment System
- Applicant
- Benvenue Medical, Inc.
Hillsborough, CA, US - Received
- May 2, 2014
- Decision date
- August 14, 2014
- 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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| 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 |
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| K221697 | Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional | Slk Ortho, LLC | 03/03/2023SE |
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| K220131 | KYPHON VuE Bone CementNDN · Traditional | Tecres S.P.A. | 04/18/2022SE |
More from Tecres S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K201427 | Trivergent Spinal Fixation SystemNKB · Traditional | 10/21/2020SE |
| K193172 | Luna XD Ti Interbody Fusion SystemMAX · Traditional | 07/02/2020SE |
| K183560 | Luna 3D GEN2 Interbody Fusion SystemMAX · Traditional | 05/23/2019SE |
| K162431 | Luna 3D Interbody Fusion SystemMAX · Traditional | 11/17/2016SE |
| K142023 | Luna Interbody SystemMAX · Traditional | 11/20/2014SE |
| K132817 | Kiva VCF Treatment SystemNDN · Traditional | 01/24/2014SE |
| K070293 | Benvenue VCF Osteo Coil SystemOCJ · Traditional | 07/10/2007SE |
Questions and answers
When was Kiva VCF Treatment System cleared by the FDA?
Kiva VCF Treatment System (K141141) received a 510(k) decision of Substantially Equivalent on August 14, 2014, 104 days after the submission was received.
What is the product code of K141141?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.