KRD1 Pedicle Screw System
FDA 510(k) K092420 · Spinefrontier, Inc.
510(k) numberK092420
Submission
- Device name
- KRD1 Pedicle Screw System
- Applicant
- Spinefrontier, Inc.
Beverly, MA, US - Received
- August 6, 2009
- Decision date
- November 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | Mighty Oak Medical, Inc. | 12/11/2015SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
More from Changzhou Waston Medical Appliance Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Special | 06/19/2020SE |
| K172484 | A-CIFT SoloFuseOVE · Traditional | 05/08/2018SE |
| K151198 | A-CIFT SoloFuseOVE · Special | 07/17/2015SE |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Traditional | 05/13/2015SE |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemOUR · Traditional | 04/24/2015SE |
| K143377 | PedFuse Pedicle Screw SystemMNH · Special | 02/12/2015SE |
| K141333 | Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceODP · Traditional | 11/25/2014SE |
| K142026 | Spinefrontier Arena-C Ha PEEK Cervical Intervertebral Body Fusion DeviceODP · Traditional | 10/20/2014SE |
| K141337 | Arena-CODP · Traditional | 09/08/2014SE |
| K133153 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Special | 05/14/2014SE |
Questions and answers
When was KRD1 Pedicle Screw System cleared by the FDA?
KRD1 Pedicle Screw System (K092420) received a 510(k) decision of Substantially Equivalent on November 19, 2009, 105 days after the submission was received.
What is the product code of K092420?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.