The following data is part of a premarket notification filed by Renerve Ltd with the FDA for Nervalign Nerve Cuff.
| Device ID | K202234 |
| 510k Number | K202234 |
| Device Name: | NervAlign Nerve Cuff |
| Classification | Cuff, Nerve |
| Applicant | Renerve Ltd Suite 3, 21 Vale Street North Melbourne, AU 3051 |
| Contact | David Rhodes |
| Correspondent | Chris Sloan Sloan Regulatory Consulting LLC 322 Hart Road Gaithersburg, MD 20878 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-07 |
| Decision Date | 2022-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09369998231904 | K202234 | 000 |
| 09369998146796 | K202234 | 000 |
| 09369998075812 | K202234 | 000 |