NervAlign Nerve Cuff

FDA 510(k) K202234 · Renerve, Ltd.

Substantially Equivalent

510(k) numberK202234

Submission

Device name
NervAlign Nerve Cuff
Applicant
Renerve, Ltd.
North Melbourne, AU
Received
August 7, 2020
Decision date
February 10, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXI – Cuff, Nerve
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5275
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code JXI

510(k)DeviceApplicantDecision
K260245SILKBridgeJXI · Traditional KLISBio S.r.l.04/09/2026SE
K253363NeuroSpan BridgeJXI · Traditional Auxilium Biotechnologies, Inc.01/17/2026SE
K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional Alafair Biosciences07/22/2025SE
K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional Alafair Biosciences07/17/2025SE
K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40…JXI · Traditional Orthocell, Ltd.04/02/2025SE
K242113Nerve Wrap (07-DW-001-TAB)JXI · Traditional Biocircuit Technologies, Inc.04/02/2025SE
K233322Mochida Nerve CuffJXI · Traditional Mochida Pharmaceutical Co., Ltd.06/21/2024SE
K233533NerveTapeJXI · Traditional Biocircuit Technologies, Inc.02/12/2024SE
K230794Rebuilder Nerve Guidance ConduitJXI · Traditional Celestray Biotech Company, LLC.,01/29/2024SE
K232029VersaWrap Nerve ProtectorJXI · Traditional Alafair Biosciences, Inc.11/02/2023SE

Questions and answers

When was NervAlign Nerve Cuff cleared by the FDA?

NervAlign Nerve Cuff (K202234) received a 510(k) decision of Substantially Equivalent on February 10, 2022, 552 days after the submission was received.

What is the product code of K202234?

The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.