BonOs Inject Bone Cement; NEO Pedicle Screw System
FDA 510(k) K212489 · Neo Medical SA
510(k) numberK212489
Submission
- Device name
- BonOs Inject Bone Cement; NEO Pedicle Screw System
- Applicant
- Neo Medical SA
Villette (Lavaux), CH - Received
- August 9, 2021
- Decision date
- October 28, 2021
- 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 |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | Icotec AG | 10/13/2020SE |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone CementPML · Traditional | Medtronic | 08/19/2020SE |
More from Medtronic
| 510(k) | Device | Decision |
|---|---|---|
| K243693 | NEO Pedicle Screw SystemNKB · Special | 12/23/2024SE |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw SystemPML · Special | 08/26/2022SE |
| K191796 | Neo Cage SystemMAX · Traditional | 12/13/2019SE |
| K181048 | Neo Cage System TMMAX · Traditional | 01/29/2019SE |
| K171582 | NEO Pedicle Screw SystemNKB · Traditional | 09/12/2017SE |
Questions and answers
When was BonOs Inject Bone Cement; NEO Pedicle Screw System cleared by the FDA?
BonOs Inject Bone Cement; NEO Pedicle Screw System (K212489) received a 510(k) decision of Substantially Equivalent on October 28, 2021, 80 days after the submission was received.
What is the product code of K212489?
The FDA product code is PML – Bone Cement, Posterior Screw Augmentation, a Class II (moderate risk) device regulated under 21 CFR 888.3027.