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Data / Medical devices / Cuff, Nerve

Cuff, Nerve (JXI): 23 FDA-registered makers in 6 countries

23 establishments in 6 countries are registered with the FDA to make Cuff, Nerve (product code JXI, Class 2, 21 CFR 882.5275). 17 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on April 9, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JXI
Device class
2
Regulation
882.5275
Medical specialty
Neurology
Implant
Yes

Makers by country

CountryMakers
United States16
Netherlands2
Australia2
Italy1
Japan1
Ireland1

Makers of Cuff, Nerve

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
Alafair Biosciences, Inc.Austin, TX, United StatesComplaint file establishment, Manufacturer, Specification developer4July 22, 2025000api.fda.gov
Biocircuit TechnologiesAtlanta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer3April 2, 2025000api.fda.gov
Collagen Matrix, Inc.Oakland, NJ, United StatesManufacturer3April 3, 2014000api.fda.gov
Cook Biotech, Inc.West Lafayette, IN, United StatesContract manufacturer, Manufacturer3October 31, 2016000api.fda.gov
Integra Lifesciences CorporationPlainsboro, NJ, United StatesManufacturer3January 6, 2017010api.fda.gov
Integra LifeSciences CorporationPrinceton, NJ, United StatesComplaint file establishment, Specification developer3January 6, 2017010api.fda.gov
Polyganics Holding BVGroningen, NetherlandsManufacturer3January 13, 2016000api.fda.gov
Axogen Corporation - Tampa HeightsTampa, FL, United StatesComplaint file establishment, Specification developer2October 12, 2023000api.fda.gov
Integra NeurosciencesAnasco, PR, United StatesManufacturer2July 16, 2004000api.fda.gov
Celestray Biotech Company, LLC.Bethesda, MD, United StatesSpecification developer1January 29, 2024000api.fda.gov
Checkpoint Surgical Inc.Brecksville, OH, United StatesSpecification developer1May 31, 2019000api.fda.gov
Checkpoint Surgical Inc.Independence, OH, United StatesSpecification developer1May 31, 2019000api.fda.gov
KLISBio S.r.l.Bresso Milano, ItalyManufacturer1April 9, 2026000api.fda.gov
Mochida Pharmaceutical Co., Ltd. Fujieda siteFujieda Shizuoka, JapanSpecification developer1June 21, 2024000api.fda.gov
Orthocell LimitedPerth Western Australia, AustraliaManufacturer1April 2, 2025000api.fda.gov
Renerve LtdMelbourne Victoria, AustraliaSpecification developer1February 10, 2022000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesManufacturer, Specification developer1March 22, 1999000api.fda.gov
AllosourceCentennial, CO, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
European Medical Contract MFG.NIJMEGEN Gelderland, NetherlandsContract manufacturer0000api.fda.gov
Kessel MedicalVero Beach, FL, United StatesContract manufacturer0000api.fda.gov
PBC BiomedShannon Clare, IrelandContract manufacturer0000api.fda.gov
Viant Medical, Inc.Grand Rapids, MI, United StatesContract manufacturer0000api.fda.gov

Updated April 9, 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.