Zenius Spinal System
FDA 510(k) K103272 · Medyssey Co, Ltd.
510(k) numberK103272
Submission
- Device name
- Zenius Spinal System
- Applicant
- Medyssey Co, Ltd.
Murray, UT, US - Received
- November 5, 2010
- Decision date
- December 29, 2010
- 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
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| 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 |
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| K121670 | Medyssey Cannulated Pedicle ScrewNKB · Traditional | 01/25/2013SE |
| K121320 | C7 Anterior Cervical Intervertebral Fusion CageODP · Traditional | 08/10/2012SE |
| K121246 | Medyssy LT Cage SystemMAX · Special | 06/15/2012SE |
| K110284 | Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special | 06/08/2011SE |
| K110283 | Zenius Spinal SystemMNI · Special | 05/19/2011SE |
| K110067 | LP CageMAX · Traditional | 04/08/2011SE |
| K103147 | Novel III Spinal Fixation and Adjustable Bridge SystemMNI · Special | 12/16/2010SE |
| K093104 | Medyssey Co., Ltd., Zenius Spinal SystemMNI · Traditional | 06/25/2010SE |
Questions and answers
When was Zenius Spinal System cleared by the FDA?
Zenius Spinal System (K103272) received a 510(k) decision of Substantially Equivalent on December 29, 2010, 54 days after the submission was received.
What is the product code of K103272?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.