Data / Medical devices / Shunt, Central Nervous System And Components
Shunt, Central Nervous System And Components (JXG): 41 FDA-registered makers in 8 countries
41 establishments in 8 countries are registered with the FDA to make Shunt, Central Nervous System And Components (product code JXG, Class 2, 21 CFR 882.5550). 19 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 260 510(k) clearances under this code, the latest on October 2, 2026, and lists 35 recall events (3 Class I). FDA data exported November 2, 2026.
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- Product code
- JXG
- Device class
- 2
- Regulation
- 882.5550
- Medical specialty
- Neurology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 24 |
| Germany | 5 |
| Switzerland | 3 |
| France | 2 |
| Mexico | 2 |
| Ireland | 2 |
| Dominican Republic | 2 |
| Malaysia | 1 |
Makers of Shunt, Central Nervous System And Components
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 39 | March 10, 2025 | 0 | 9 | 2 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer, Specification developer | 32 | June 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Switzerland Sarl | Le Locle Neuchatel, Switzerland | Manufacturer | 31 | June 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 22 | October 11, 2019 | 0 | 1 | 0 | api.fda.gov |
| Natus Medical Incorporated | San Diego, CA, United States | Complaint file establishment, Specification developer | 20 | October 28, 2016 | 0 | 2 | 0 | api.fda.gov |
| Sophysa | BESANCON Doubs, France | Manufacturer | 11 | November 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sophysa | ORSAY, CEDEX Essonne, France | Manufacturer | 11 | November 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| christoph miethke gmbh & co.kg | potsdam Brandenburg, Germany | Manufacturer | 11 | May 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 8 | March 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Christoph Miethke GMBH & Co.kg | potsdam Brandenburg, Germany | Complaint file establishment, Manufacturer | 5 | December 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 5 | November 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Anuncia Medical, Inc. | Scottsdale, AZ, United States | Complaint file establishment, Specification developer | 2 | December 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 2 | October 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Moeller Medical GMBH | FULDA Hesse, Germany | Manufacturer | 2 | December 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Phasor Health, LLC | Houston, TX, United States | Complaint file establishment, Manufacturer | 2 | November 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Borvo Medical, Inc. | Mountain View, CA, United States | Complaint file establishment, Specification developer | 1 | August 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| BRAINSPACE Inc | Bothell, WA, United States | Manufacturer | 1 | December 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences (ireland) Limited | SRAGH TULLAMORE Offaly, Ireland | Manufacturer | 1 | October 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Ireland | GALWAY Galway(County), Ireland | Manufacturer | 1 | November 18, 2011 | 0 | 0 | 0 | api.fda.gov |
| Boulder Biomed LLC | Boulder, CO, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Industries, Inc. | Latrobe, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fmi LLC | Lincolnshire, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HMT Microelectronic AG | Biel Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing | Somersworth, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Dominicana, S.A.S. | La Romana, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medeologix LLC | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcision LLC | Pennsauken, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PMC SMART Solutions, LLC | Shelbyville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qualitel Corporation | Everett, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remedy Medical Manufacturing | Mesa, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rose Medical | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical - Dartmouth, MA | Dartmouth, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 2, 2026. 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.