Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
FDA 510(k) K152557 · G21, S.R.L.
510(k) numberK152557
Submission
- Device name
- Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
- Applicant
- G21, S.R.L.
San Possidonio, IT - Received
- September 8, 2015
- Decision date
- February 23, 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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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K252443 | SpaceFix Shoulder SpacerMBB · Traditional | 09/15/2025SE |
| K223441 | SpaceFlex Acetabular CupKWY · Traditional | 03/23/2023SE |
| K202338 | SpaceFlex ShoulderMBB · Traditional | 02/17/2021SE |
| K201960 | SpaceFlex Knee - 80mm SizeMBB · Special | 08/13/2020SE |
| K193061 | G3 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K193059 | G1 40 Radiopaque Bone CementLOD · Traditional | 03/19/2020SE |
| K192041 | G21 SpaceFlex HipMBB · Traditional | 10/29/2019SE |
| K190216 | SpaceFlex KneeMBB · Traditional | 06/09/2019SE |
| K181282 | G3A 40 Bone CementLOD · Traditional | 01/09/2019SE |
| K173494 | OrthoSteady G Bone CementLOD · Traditional | 03/06/2018SE |
Questions and answers
When was Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters cleared by the FDA?
Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (K152557) received a 510(k) decision of Substantially Equivalent on February 23, 2016, 168 days after the submission was received.
What is the product code of K152557?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.