Confidence Fenestrated Introducer Needle
FDA 510(k) K063067 · Disc-O-Tech Medical Technologies, Ltd.
510(k) numberK063067
Submission
- Device name
- Confidence Fenestrated Introducer Needle
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
Washington, DC, US - Received
- October 6, 2006
- Decision date
- November 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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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 |
|---|---|---|
| K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)NDN · Traditional | 12/21/2007SE |
| K071679 | Metafix and Fixion Fa Intramedullary Nailing SystemsHSB · Traditional | 12/17/2007SE |
| K062424 | Confidence Ex High Viscosity Bone CementNDN · Special | 09/14/2006SE |
| K060300 | Confidence High Viscosity Bone CementNDN · Traditional | 06/21/2006SE |
| K040612 | Sky Bone Expander System (Sky System)HRX · Traditional | 06/17/2004SE |
| K040939 | Sky Bone Expander System (Sky System)HRX · Special | 05/12/2004SE |
| K032730 | Fixion Hip SystemJDI · Traditional | 03/26/2004SE |
| K034037 | Sky Bone Expander SystemHRX · Special | 01/28/2004SE |
| K032358 | B-Twin Bone Expander System (B-Twin Be System)HRX · Traditional | 12/17/2003SE |
| K030972 | Fixion Unipolar Modular Hemi-Hip System (Fixion MH)KWL · Special | 05/30/2003SE |
Questions and answers
When was Confidence Fenestrated Introducer Needle cleared by the FDA?
Confidence Fenestrated Introducer Needle (K063067) received a 510(k) decision of Substantially Equivalent on November 3, 2006, 28 days after the submission was received.
What is the product code of K063067?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.