Vertecem II Cement Kit
FDA 510(k) K121876 · Aap Biomaterials GmbH
510(k) numberK121876
Submission
- Device name
- Vertecem II Cement Kit
- Applicant
- Aap Biomaterials GmbH
Dieburg, DE - Received
- June 27, 2012
- Decision date
- October 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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|---|---|---|---|
| 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 |
|---|---|---|
| K123225 | Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60LOD · Abbreviated | 03/15/2013SE |
| K123081 | Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40…LOD · Abbreviated | 03/07/2013SE |
| K090460 | Bonos InjectNDN · Abbreviated | 04/14/2009SE |
Questions and answers
When was Vertecem II Cement Kit cleared by the FDA?
Vertecem II Cement Kit (K121876) received a 510(k) decision of Substantially Equivalent on October 19, 2012, 114 days after the submission was received.
What is the product code of K121876?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.