FDA product code MNI: Orthosis, Spinal Pedicle Fixation
MNI is the FDA product code for orthosis, spinal pedicle fixation. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 303 510(k) submissions under MNI, from 126 different applicants. The average 510(k) review took 95 days (median 73). FDA has posted 213 recalls for MNI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Spinal Pedicle Fixation |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MNI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 143 |
Compare with all 510(k) review times · Search every MNI clearance
Top MNI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| K2m, Inc. | 14 | 2013-11-20 |
| Medtronic Sofamor Danek, Inc. | 12 | 2006-12-22 |
| Spine Wave, Inc. | 11 | 2016-02-26 |
| Medtronic Sofamor Danek | 11 | 2006-09-25 |
| Spinal USA | 8 | 2013-07-24 |
121 more applicants have MNI clearances. See the full list in Caduvo.
Most recent MNI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171497 | Mikron Makina Sanayi Ticaret Co. , Ltd. | Mikron Spinal Fixation System | 2017-10-12 | 143 |
| K160731 | CG Bio Co., Ltd. | LumFix Spinal Fixation Sytem | 2016-10-04 | 201 |
| K151458 | Double Medical Technology, Inc. | Double Medical Universal Spine System | 2016-08-22 | 448 |
| K153273 | Medacta International S.A. | MySpine Pedicle Screw Placement Guides - LP | 2016-06-29 | 230 |
| K160124 | Spinevision S.A. | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | 2016-04-04 | 75 |
Recalls for MNI devices
213 product recalls in 32 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-02-18.
| Year | Recalls |
|---|---|
| 2017 | 145 |
| 2018 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code MNI?
MNI is the FDA product code for orthosis, spinal pedicle fixation. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is MNI?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNI?
Across 303 cleared submissions the average was 95 days from receipt to decision (median 73).
Which companies have the most MNI clearances?
K2m, Inc. (14); Medtronic Sofamor Danek, Inc. (12); Spine Wave, Inc. (11); Medtronic Sofamor Danek (11); Spinal USA (8).
Have MNI devices been recalled?
Yes: 213 product recalls across 32 recall events; the most recent began 2026-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MNI
- Run a recall and safety report across every MNI manufacturer
- Watch product code MNI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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