High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
FDA 510(k) K190526 · CarboFix Orthopedics , Ltd.
510(k) numberK190526
Submission
- Device name
- High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws
- Applicant
- CarboFix Orthopedics , Ltd.
Herzeliya, IL - Received
- March 4, 2019
- Decision date
- September 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PML – Bone Cement, Posterior Screw Augmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
The device is intended to augment the fixation of screws in a posterior spinal system construct.
Other 510(k)s with product code PML
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | Spine Wave, Inc. | 06/15/2026SE |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | Astura Medical | 01/22/2026SE |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemPML · Traditional | Medacta International S.A. | 06/12/2024SE |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…PML · Traditional | Ulrich Medical USA | 10/20/2023SE |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone CementPML · Traditional | Spineart | 06/23/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | Icotec AG | 01/09/2023SE |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation SystemPML · Traditional | Alphatec Spine, Inc. | 12/20/2022SE |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw SystemPML · Special | Neo Medical SA | 08/26/2022SE |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw SystemPML · Traditional | Neo Medical SA | 10/28/2021SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | Icotec AG | 10/13/2020SE |
More from Icotec AG
| 510(k) | Device | Decision |
|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | 03/16/2026SE |
| K243106 | CarboClear® Hybrid Pedicle Screw SystemNKB · Traditional | 11/05/2024SE |
| K233793 | CarboClear® X Pedicle Screw SystemNKB · Traditional | 08/01/2024SE |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…NKB · Special | 04/25/2024SE |
| K233989 | CarboClear® Posterior Cervical Screw SystemNKG · Traditional | 03/27/2024SE |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsNKB · Special | 01/10/2024SE |
| K232341 | CarboClear® Pedicle Screw SystemNKB · Traditional | 10/10/2023SE |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…NKB · Traditional | 07/03/2023SE |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsNKB · Special | 04/06/2021SE |
| K203317 | CarboClear X Pedicle Screw SystemNKB · Special | 11/25/2020SE |
Questions and answers
When was High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws cleared by the FDA?
High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (K190526) received a 510(k) decision of Substantially Equivalent on September 19, 2019, 199 days after the submission was received.
What is the product code of K190526?
The FDA product code is PML – Bone Cement, Posterior Screw Augmentation, a Class II (moderate risk) device regulated under 21 CFR 888.3027.