Data / Medical devices / Manipulator, Plunger-Like Joint
Manipulator, Plunger-Like Joint (LXM): 12 FDA-registered makers in 2 countries
12 establishments in 2 countries are registered with the FDA to make Manipulator, Plunger-Like Joint (product code LXM, Class U). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on February 15, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LXM
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Canada | 2 |
Makers of Manipulator, Plunger-Like Joint
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Activator Methods International Ltd. | Phoenix, AZ, United States | Manufacturer | 3 | March 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Neuromechanical Innovations, LLC | Phoenix, AZ, United States | Manufacturer | 2 | April 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Hill Laboratories | Frazer, PA, United States | Manufacturer | 1 | June 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer | 1 | April 30, 1996 | 0 | 0 | 0 | api.fda.gov |
| JTECH Medical Industries, Inc. | Midvale, UT, United States | Manufacturer | 1 | February 18, 1998 | 0 | 0 | 0 | api.fda.gov |
| Neuro Spinal Innovation Inc (nsi) | Mississauga Ontario, Canada | Specification developer | 1 | February 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sense Technology, Inc. | Halifax, PA, United States | Manufacturer, Specification developer | 1 | June 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Sigma Instruments, Inc. | Cranberry Township, PA, United States | Manufacturer | 1 | January 10, 1997 | 0 | 0 | 0 | api.fda.gov |
| Spinalight Inc | St Petersburg, FL, United States | Manufacturer | 1 | June 20, 2018 | 0 | 1 | 0 | api.fda.gov |
| Sweat Institute | Atlanta, GA, United States | Manufacturer | 1 | November 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| Hardy Manufacturing | Decatur, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMF Design and Manufacturing Inc. | Mississauga Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.