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
| Country | Makers |
|---|---|
| United States | 16 |
| Netherlands | 2 |
| Australia | 2 |
| Italy | 1 |
| Japan | 1 |
| Ireland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alafair Biosciences, Inc. | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | July 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biocircuit Technologies | Atlanta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Oakland, NJ, United States | Manufacturer | 3 | April 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Contract manufacturer, Manufacturer | 3 | October 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Plainsboro, NJ, United States | Manufacturer | 3 | January 6, 2017 | 0 | 1 | 0 | api.fda.gov |
| Integra LifeSciences Corporation | Princeton, NJ, United States | Complaint file establishment, Specification developer | 3 | January 6, 2017 | 0 | 1 | 0 | api.fda.gov |
| Polyganics Holding BV | Groningen, Netherlands | Manufacturer | 3 | January 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Axogen Corporation - Tampa Heights | Tampa, FL, United States | Complaint file establishment, Specification developer | 2 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 2 | July 16, 2004 | 0 | 0 | 0 | api.fda.gov |
| Celestray Biotech Company, LLC. | Bethesda, MD, United States | Specification developer | 1 | January 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Checkpoint Surgical Inc. | Brecksville, OH, United States | Specification developer | 1 | May 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| Checkpoint Surgical Inc. | Independence, OH, United States | Specification developer | 1 | May 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| KLISBio S.r.l. | Bresso Milano, Italy | Manufacturer | 1 | April 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mochida Pharmaceutical Co., Ltd. Fujieda site | Fujieda Shizuoka, Japan | Specification developer | 1 | June 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Orthocell Limited | Perth Western Australia, Australia | Manufacturer | 1 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Renerve Ltd | Melbourne Victoria, Australia | Specification developer | 1 | February 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Manufacturer, Specification developer | 1 | March 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Allosource | Centennial, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| European Medical Contract MFG. | NIJMEGEN Gelderland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kessel Medical | Vero Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PBC Biomed | Shannon Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, Inc. | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.