Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022317591

FEI Number

3022317591

Entity Name

RENERVE LTD

City/State/Country

Melbourne Victoria, AU

Establishment Address

L 10 99 Queen Street, Melbourne Victoria 3000, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ReNerve Ltd (Owner Number: 10084457)

Owner / Operator Contact Address

Level 10, 99 Queen Street, Melbourne, AU-VIC 3000, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202234

PMA Number

N/A

All Registered Proprietary Names

NervAlign Nerve Cuff

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2022-04-01

Official Correspondent

David Rhodes

US Agent Details

Matt Kyle Business: Kuro Medical LLC Email: quality@kuromedical.com Phone: (612) 6362035

Related Public Records

Same Entity

ReNerve Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022317591. Last updated year: 2026. Please use registration number 3022317591 when referencing this establishment in official correspondence.