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Data / Medical devices / Stimulator, Spinal-Cord, Implanted (Pain Relief)

Stimulator, Spinal-Cord, Implanted (Pain Relief) (GZB): 24 FDA-registered makers in 5 countries

24 establishments in 5 countries are registered with the FDA to make Stimulator, Spinal-Cord, Implanted (Pain Relief) (product code GZB, Class 2, 21 CFR 882.5880). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 139 510(k) clearances under this code, the latest on August 23, 2024, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
GZB
Device class
2
Regulation
882.5880
Medical specialty
Neurology
Implant
Yes

Makers by country

CountryMakers
United States19
India2
Mexico1
Malaysia1
Costa Rica1

Makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)

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
Abbott MedicalPlano, TX, United StatesManufacturer11May 2, 2014020api.fda.gov
Curonix LLCPompano Beach, FL, United StatesComplaint file establishment, Manufacturer, Specification developer9November 7, 2019000api.fda.gov
Medtronic NeuromodulationMinneapolis, MN, United StatesManufacturer7October 26, 2010020api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer3August 16, 2006000api.fda.gov
Boston Scientific Neuromodulation CorporationValencia, CA, United StatesComplaint file establishment, Specification developer2August 23, 2024010api.fda.gov
Medtronic Puerto Rico Operations Co., JuncosJuncos, PR, United StatesManufacturer2October 26, 2010000api.fda.gov
Abbott MedicalArecibo, PR, United StatesManufacturer1May 22, 1996000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesManufacturer1February 23, 2012000api.fda.gov
Nalu MedicalCarlsbad, CA, United StatesManufacturer, Specification developer1August 23, 2024000api.fda.gov
Armor Plast LtdBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
AUSA Medical Device Pvt LtdBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
Cirtec MedicalEnfield, CT, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Heraeus Medical Components, LLCSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
MiniStim CorpBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Oscor Inc.Palm Harbor, FL, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Plexus Manufacturing Sdn. Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Spectrum Assembly Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Technical Services For Electronics, Inc.Jackson, MN, United StatesContract manufacturer0000api.fda.gov
Tegra Medical Costa Rica S.A.La Aurora Heredia, Costa RicaContract manufacturer0000api.fda.gov

Updated August 23, 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.