Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
JXG
Device class
2
Regulation
882.5550
Medical specialty
Neurology
Implant
Yes

Makers by country

CountryMakers
United States24
Germany5
Switzerland3
France2
Mexico2
Ireland2
Dominican Republic2
Malaysia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer39March 10, 2025092api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer32June 23, 2026000api.fda.gov
Integra LifeSciences Switzerland SarlLe Locle Neuchatel, SwitzerlandManufacturer31June 23, 2026000api.fda.gov
Integra NeurosciencesAnasco, PR, United StatesManufacturer22October 11, 2019010api.fda.gov
Natus Medical IncorporatedSan Diego, CA, United StatesComplaint file establishment, Specification developer20October 28, 2016020api.fda.gov
SophysaBESANCON Doubs, FranceManufacturer11November 28, 2025000api.fda.gov
SophysaORSAY, CEDEX Essonne, FranceManufacturer11November 28, 2025000api.fda.gov
christoph miethke gmbh & co.kgpotsdam Brandenburg, GermanyManufacturer11May 8, 2020000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer8March 10, 2025000api.fda.gov
Christoph Miethke GMBH & Co.kgpotsdam Brandenburg, GermanyComplaint file establishment, Manufacturer5December 16, 2024000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer5November 20, 2018000api.fda.gov
Anuncia Medical, Inc.Scottsdale, AZ, United StatesComplaint file establishment, Specification developer2December 29, 2022000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer2October 19, 2023000api.fda.gov
Moeller Medical GMBHFULDA Hesse, GermanyManufacturer2December 18, 2015000api.fda.gov
Phasor Health, LLCHouston, TX, United StatesComplaint file establishment, Manufacturer2November 5, 2025000api.fda.gov
Borvo Medical, Inc.Mountain View, CA, United StatesComplaint file establishment, Specification developer1August 20, 2024000api.fda.gov
BRAINSPACE IncBothell, WA, United StatesManufacturer1December 10, 2025000api.fda.gov
Integra Lifesciences (ireland) LimitedSRAGH TULLAMORE Offaly, IrelandManufacturer1October 25, 2018000api.fda.gov
Medtronic IrelandGALWAY Galway(County), IrelandManufacturer1November 18, 2011000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Classic Industries, Inc.Latrobe, PA, United StatesContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fmi LLCLincolnshire, IL, United StatesContract manufacturer0000api.fda.gov
HMT Microelectronic AGBiel Bern, SwitzerlandContract manufacturer0000api.fda.gov
Life Science OutsourcingSomersworth, NH, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Microtek Dominicana, S.A.S.La Romana, Dominican RepublicContract manufacturer0000api.fda.gov
Medeologix LLCSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
PMC SMART Solutions, LLCShelbyville, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Plexus Manufacturing Sdn. Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Remedy Medical ManufacturingMesa, AZ, United StatesContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Rose MedicalGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Tegra Medical - Dartmouth, MADartmouth, MA, United StatesContract manufacturer0000api.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.