Kyphx Hv-R, Model C01A
FDA 510(k) K033801 · Kyphon, Inc.
510(k) numberK033801
Submission
- Device name
- Kyphx Hv-R, Model C01A
- Applicant
- Kyphon, Inc.
Sunnyvale, CA, US - Received
- December 8, 2003
- Decision date
- April 1, 2004
- 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 |
|---|---|---|
| K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…BSP · Traditional | 02/21/2008SE |
| K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BBSP · Special | 04/13/2007SE |
| K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…BSP · Special | 06/27/2006SE |
| K041454 | Kyphx Xpander Inflatable Bone Tamps MODEL#KO8A,KO9A,K13AHRX · Traditional | 07/09/2004SE |
| K041584 | Kyphx Hv-R Bone Cement, Model C01ANDN · Traditional | 07/07/2004SE |
| K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AHRX · Traditional | 09/15/2003SE |
| K010246 | Kyphx Inflatable Bone Tamp, Size 20/3,MODEL K01A, Kyphx Inflatable Bone Tamp, Size 15/3…HRX · Traditional | 02/14/2001SE |
| K981251 | Kyphon Inflatable Bone TampHRX · Traditional | 07/02/1998SE |
Questions and answers
When was Kyphx Hv-R, Model C01A cleared by the FDA?
Kyphx Hv-R, Model C01A (K033801) received a 510(k) decision of Substantially Equivalent on April 1, 2004, 115 days after the submission was received.
What is the product code of K033801?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.