FDA product code LXM: Manipulator, Plunger-Like Joint
LXM is the FDA product code for manipulator, plunger-like joint. It is a Unclassified device, reviewed by the Physical Medicine panel. FDA has cleared 32 510(k) submissions under LXM, 1 in the last five years, from 21 different applicants. The average 510(k) review took 189 days (median 146); 56 days on average over the last three years. FDA has posted 1 recall for LXM devices.
Classification
| Field | Value |
|---|---|
| Device name | Manipulator, Plunger-Like Joint |
| Device class | Unclassified |
| Review panel | PM — Physical Medicine |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LXM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 302 |
| 2019 | 1 | 89 |
| 2024 | 1 | 56 |
Compare with all 510(k) review times · Search every LXM clearance
Top LXM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Technology, Inc. | 5 | 1992-09-30 |
| Spinalight, Inc. | 4 | 2018-06-20 |
| Activator Methods International, Ltd. | 3 | 2012-03-06 |
| Neuromechanical Innovations, LLC | 2 | 2008-04-11 |
| Sense Technology, Inc. | 2 | 1998-06-30 |
16 more applicants have LXM clearances. See the full list in Caduvo.
Most recent LXM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234036 | Neuro Spinal Innovation, Inc. | SONIK MONARK 100 | 2024-02-15 | 56 |
| K192629 | Optima Health Solutions International Corp. | Spinalytics | 2019-12-21 | 89 |
| K172536 | Spinalight, Inc. | Atlas Percussion Adjusting Instrument | 2018-06-20 | 302 |
| K160278 | Spinal Acoustics, LLC | VSTAAR AdjusteR | 2016-11-04 | 276 |
| K130666 | Optima Health Solutions International Corporation | KHAN KINETIC TREATMENT (KKT-M2) | 2014-01-23 | 317 |
Recalls for LXM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-03-06.
Frequently asked questions
What is FDA product code LXM?
LXM is the FDA product code for manipulator, plunger-like joint. It is a Unclassified device, reviewed by the Physical Medicine panel.
What device class is LXM?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXM?
Across 32 cleared submissions the average was 189 days from receipt to decision (median 146).
Which companies have the most LXM clearances?
Kinetic Technology, Inc. (5); Spinalight, Inc. (4); Activator Methods International, Ltd. (3); Neuromechanical Innovations, LLC (2); Sense Technology, Inc. (2).
Have LXM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code LXM
- Run a recall and safety report across every LXM manufacturer
- Watch product code LXM 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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