FDA product code MNH: Orthosis, Spondylolisthesis Spinal Fixation
MNH is the FDA product code for orthosis, spondylolisthesis spinal fixation. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 309 510(k) submissions under MNH, from 145 different applicants. The average 510(k) review took 127 days (median 90). FDA has posted 15 recalls for MNH devices.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MNH clearance
Top MNH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acromed Corp. | 14 | 1998-06-30 |
| Medtronic Sofamor Danek, Inc. | 13 | 2004-02-12 |
| Depuyacromed | 13 | 2003-02-26 |
| Sofamor Danek USA,Inc. | 9 | 2000-05-10 |
| Advanced Spine Fixation Systems, Inc. | 8 | 1995-11-07 |
140 more applicants have MNH clearances. See the full list in Caduvo.
Most recent MNH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162066 | Reliance Medical Systems, LLC | Reliance Spinal Screw System | 2016-12-02 | 129 |
| K162801 | L&K BIOMED Co., Ltd. | CastleLoc Spinal Fixation System | 2016-11-03 | 29 |
| K162143 | Innovasis, Inc. | FixxSure® X-Link | 2016-09-23 | 53 |
| K161151 | Canwell Medical Co., Ltd. | Spinal fixation system | 2016-09-21 | 149 |
| K162189 | U&I Corporation | ANAX 5.5 Spinal System | 2016-08-30 | 26 |
Recalls for MNH devices
15 product recalls in 12 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code MNH?
MNH is the FDA product code for orthosis, spondylolisthesis spinal fixation. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is MNH?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNH?
Across 309 cleared submissions the average was 127 days from receipt to decision (median 90).
Which companies have the most MNH clearances?
Acromed Corp. (14); Medtronic Sofamor Danek, Inc. (13); Depuyacromed (13); Sofamor Danek USA,Inc. (9); Advanced Spine Fixation Systems, Inc. (8).
Have MNH devices been recalled?
Yes: 15 product recalls across 12 recall events; the most recent began 2017-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MNH
- Run a recall and safety report across every MNH manufacturer
- Watch product code MNH 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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