F20
FDA 510(k) K103433 · Teknimed, S.A.
510(k) numberK103433
Submission
- Device name
- F20
- Applicant
- Teknimed, S.A.
Round Rock, TX, US - Received
- November 24, 2010
- Decision date
- January 3, 2011
- 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
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 |
|---|---|---|
| K090435 | VertecemNDN · Special | 12/21/2009SE |
| K083005 | NangelLYC · Traditional | 03/04/2009SE |
| K080873 | Opacity + Bone CementNDN · Special | 08/28/2008SE |
| K062102 | OdoncerLYC · Traditional | 04/16/2007SE |
| K043593 | Spine-Fix Biomimetic Bone CementNDN · Traditional | 03/17/2006SE |
| K042911 | Cementek LVMQV · Special | 12/27/2004SE |
| K041493 | CementekMQV · Traditional | 08/19/2004SE |
| K040669 | Ceraform Bone Void FillerMQV · Special | 05/03/2004SE |
| K031826 | Triha +MQV · Traditional | 11/28/2003SE |
| K032685 | Cemstop Cement RestrictorLZN · Traditional | 11/26/2003SE |
Questions and answers
When was F20 cleared by the FDA?
F20 (K103433) received a 510(k) decision of Substantially Equivalent on January 3, 2011, 40 days after the submission was received.
What is the product code of K103433?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.