MEDINAUT Kyphoplasty System
FDA 510(k) K153296 · Imedicom Co., Ltd.
510(k) numberK153296
Submission
- Device name
- MEDINAUT Kyphoplasty System
- Applicant
- Imedicom Co., Ltd.
Gunpo-Si, KR - Received
- November 13, 2015
- Decision date
- July 29, 2016
- 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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| 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 |
More from Tecres S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K182287 | MEDINAUT PlusHRX · Traditional | 04/06/2019SE |
| K173541 | EpinautBSO · Traditional | 08/24/2018SE |
| K150915 | Spinaut-PGEI · Traditional | 03/18/2016SE |
| K151268 | Spinaut-V, Spinaut-S, Spinaut-IHRX · Traditional | 03/16/2016SE |
| K150789 | Spinaut-E, Spinaut-IBSO · Traditional | 03/01/2016SE |
| K133669 | Medinaut Kyphoplasty SystemNDN · Traditional | 04/04/2014SE |
Questions and answers
When was MEDINAUT Kyphoplasty System cleared by the FDA?
MEDINAUT Kyphoplasty System (K153296) received a 510(k) decision of Substantially Equivalent on July 29, 2016, 259 days after the submission was received.
What is the product code of K153296?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.