Mendec Spine HV, Mendec Spine HV System
FDA 510(k) K122175 · Tecres S.P.A.
510(k) numberK122175
Submission
- Device name
- Mendec Spine HV, Mendec Spine HV System
- Applicant
- Tecres S.P.A.
Rockville, MD, US - Received
- July 23, 2012
- Decision date
- March 28, 2013
- 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
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| 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 |
|---|---|---|
| K252326 | InterSpace GV Hip SpacerKWL · Special | 08/06/2025SE |
| K211163 | Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional | 01/09/2023SE |
| K220131 | KYPHON VuE Bone CementNDN · Traditional | 04/18/2022SE |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATSJWH · Traditional | 04/27/2019SE |
| K112983 | Spacer-SHSD · Traditional | 12/12/2011SE |
| K101356 | Spacer-G and Spacer-KKWL · Traditional | 09/20/2011SE |
| K092773 | Cemex Genta, Genta System and Genta System FastLOD · Special | 11/24/2009SE |
| K062274 | Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321JWH · Traditional | 05/22/2008SE |
| K062273 | Spacer-G Temporary Hip ProsthesisKWL · Traditional | 05/22/2008SE |
| K063438 | VspspnNDN · Traditional | 01/17/2007SE |
Questions and answers
When was Mendec Spine HV, Mendec Spine HV System cleared by the FDA?
Mendec Spine HV, Mendec Spine HV System (K122175) received a 510(k) decision of Substantially Equivalent on March 28, 2013, 248 days after the submission was received.
What is the product code of K122175?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.