FDA product code · Orthopedic
MNHOrthosis, Spondylolisthesis Spinal Fixation
Product code MNH covers Orthosis, Spondylolisthesis Spinal Fixation, a Class II device regulated under 21 CFR 888.3070. FDA has cleared 309 devices in this code. Median review time across the 309 most recent decisions is 90 days. openFDA lists 15 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3070
- Review panel
- Orthopedic
- Clearances
- 309
What is happening in MNH right now?
MNH (Orthosis, Spondylolisthesis Spinal Fixation): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in MNH?
FDA has cleared 309 devices under product code MNH since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | |
| K162189 | ANAX 5.5 Spinal System | U&I Corporation | |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | |
| K153404 | Zavation Spinal System | Zavation, LLC | |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | |
| K151695 | Romeo posterior osteosynthesis system | Spineart |
How long does FDA review take for MNH?
The median FDA review time for MNH is 90 days, measured across the 309 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MNH?
openFDA lists 15 recall records against product code MNH. A recall record covers one firm's corrective action and may span many device lots.
Z-1884-2017TerminatedXTANT MEDICAL INC
The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
Z-0883-2017TerminatedAmendia, Inc dba Spinal Elements
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Z-1823-2015TerminatedX Spine Systems Inc
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
Z-1512-2015TerminatedX Spine Systems Inc
One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
Z-0938-2013TerminatedSynthes USA HQ, Inc.
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Showing the 5 most recently initiated of 15. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MNH?
MAUDE holds 514 adverse-event reports naming product code MNH, 49 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MNH unusual?
Every month with enough history behind it falls inside MNH's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 156 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 5 | 0–96 | Within expected (0–96) | |
| 11 | 0–83 | Within expected (0–83) | |
| 21 | 0–95 | Within expected (0–95) | |
| 5 | 0–24 | Within expected (0–24) | |
| 17 | 0–21 | Within expected (0–21) | |
| 3 | 0–25 | Within expected (0–25) | |
| 5 | 0–35 | Within expected (0–35) | |
| 3 | 0–24 | Within expected (0–24) | |
| 4 | 0–23 | Within expected (0–23) | |
| 3 | 0–22 | Within expected (0–22) | |
| 3 | 0–19 | Within expected (0–19) | |
| 4 | 0–21 | Within expected (0–21) | |
| 20 | 0–24 | Within expected (0–24) | |
| 5 | 0–25 | Within expected (0–25) | |
| 8 | 0–26 | Within expected (0–26) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MNH.
What are the predicate devices in MNH?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MNH?
Across the 309 most recent decisions, these applicants filed most often in MNH.
| Applicant | Recent clearances |
|---|---|
| Acromed Corp. | 14 |
| Depuyacromed | 13 |
| Medtronic Sofamor Danek, Inc. | 13 |
| Sofamor Danek USA,Inc. | 9 |
| Advanced Spine Fixation Systems, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in MNH file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Medtronic Sofamor Danek, Inc. | 17 | 2 |
| Howmedica Osteonics Corp. | 9 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MNH
Get an email the morning anything changes in MNH — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Orthopedic
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.