Product code MNI: 510(k) clearances and predicates
Product code MNI covers Mikron Spinal Fixation System. FDA lists 303 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
303 clearances on file under product code MNI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest MNI clearances in the FDA index, with applicant and decision date:
- K171497, Mikron Spinal Fixation System, applicant Mikron Makina Sanayi Ticaret Co. , Ltd., decided 2017-10-12. FDA record
- K160731, LumFix Spinal Fixation Sytem, applicant CG Bio Co., Ltd., decided 2016-10-04. FDA record
- K151458, Double Medical Universal Spine System, applicant Double Medical Technology, Inc., decided 2016-08-22. FDA record
- K153273, MySpine Pedicle Screw Placement Guides - LP, applicant Medacta International S.A., decided 2016-06-29. FDA record
- K160124, LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System, applicant Spinevision S.A., decided 2016-04-04. FDA record
- K160320, Premier, applicant Shandong Weigao Orthopaedic Device Co., Ltd., decided 2016-04-01. FDA record
- K160003, Sniper (R) Spine System, applicant Spine Wave, Inc., decided 2016-02-26. FDA record
- K152324, YAHUA Spinal System, applicant Beijing Weigao Yahua Artificial Joint Development Co. , Ltd., decided 2016-02-01. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include LumFix Spinal Fixation Sytem, Double Medical Universal Spine System. Watch new MNI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MNI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MNI clearances include Mikron Spinal Fixation System.
How many 510(k) clearances use product code MNI?
303 at the time this page was generated, from openFDA records.
How do I find a predicate device under MNI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MNI clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.