Ivas 20MM (10 Gauge) Balloon Catheter
FDA 510(k) K113477 · Stryker Instruments, Instruments Div.
510(k) numberK113477
Submission
- Device name
- Ivas 20MM (10 Gauge) Balloon Catheter
- Applicant
- Stryker Instruments, Instruments Div.
Kalamazoo, MI, US - Received
- November 23, 2011
- Decision date
- January 6, 2012
- 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 |
More from Tecres S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K123178 | Stryker Venom Electrodes and CannulaeGXI · Traditional | 03/28/2013SE |
| K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM(10 GAUGE)0705-115-500, Ivas…NDN · Traditional | 03/18/2010SE |
| K072702 | Stryker Antimic CatheterBSO · Traditional | 03/19/2008SE |
| K073017 | Stryker Stri-Shield Flyte TogasFYA · Special | 11/30/2007SE |
| K070078 | Stryker T4 Hytrel TogaFYA · Special | 02/02/2007SE |
Questions and answers
When was Ivas 20MM (10 Gauge) Balloon Catheter cleared by the FDA?
Ivas 20MM (10 Gauge) Balloon Catheter (K113477) received a 510(k) decision of Substantially Equivalent on January 6, 2012, 44 days after the submission was received.
What is the product code of K113477?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.