LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
FDA 510(k) K160124 · Spinevision S.A.
510(k) numberK160124
Submission
- Device name
- LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
- Applicant
- Spinevision S.A.
Antony, FR - Received
- January 20, 2016
- Decision date
- April 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K152132 | X-spine Pedicle Screw SystemMNI · Traditional | X-Spine Systems, Inc. | 09/25/2015SE |
More from X-Spine Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFMAX · Traditional | 05/04/2016SE |
| K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…MNH · Traditional | 06/30/2014SE |
| K130302 | Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…MNI · Special | 07/30/2013SE |
| K112607 | Spinevision Lumis(Tm) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…NKB · Traditional | 06/07/2012SE |
Questions and answers
When was LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System cleared by the FDA?
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (K160124) received a 510(k) decision of Substantially Equivalent on April 4, 2016, 75 days after the submission was received.
What is the product code of K160124?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.